34 Regulatory Environments jobs in South Africa

The Apex Group was established in Bermuda in 2003 and is now one of the world's largest fund administration and middle office solutions providers.

Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion.

That's why, at Apex Group, we will do more than simply 'empower' you. We will work to supercharge your unique skills and experience.

Take the lead and we'll give you the support you need to be at the top of your game. And we offer you the freedom to be a positive disrupter and turn big ideas into bold, industry-changing realities.

For our business, for clients, and for you

Description
As an Administrator within the Client Compliance Team, you are responsible for providing high quality support and assistance to the Client Compliance Officers and Senior administrators on various fund structures such as Managed Entities/Jersey Regulated Collective Investment Funds, Jersey Private Funds, non-regulated Funds and Schedule 2 entities to which Apex services are provided.

Job Specifications

• Comply with all internal policies and procedures applicable this role and the wider business
• Ensure that all prescribed training is carried out and completed in a timely manner Assist in the completion of Compliance Monitoring programme's in relation to testing and reporting.
• Assist in the completion of compliance data reconciliation and reporting
• Assist in the drafting of Client Board Compliance reports and packs
• Carry out duties in support of the Senior Members of the Apex Client Compliance Function
• Ensure Business as usual requirements and timed reporting requirements are met Undertake or assist in any planned or ad hoc project work that is identified and become involved with Apex Group initiatives in relation to regulatory, Team or Business issues, liaising with Senior Members of the team and other stakeholders as and when required.
• Assist other team members where required
• Liaise with other Apex business employees on day to day regulatory and compliance matters and assist or appropriately direct queries regarding relevant laws, orders or codes of practice
• Provide support to third party administrators in relation to administrative requests
• Assist in the maintenance and monitoring of registers

Skills Required

• Have a good working knowledge of Microsoft products, in particular Outlook, Word and Excel as well as having the capability to quickly assimilate working with Apex's key databases.
• Excellent communication skills.
• Be well organized.
• Have the flexibility and adaptability to undertake a variety of tasks at short notice if required.
• Be proactive in your approach; self-motivated, and capable of prioritising workloads as required.
• Knowledge of the Financial Services (Jersey) Law 1998, and any orders issued under the Law.
• Knowledge of the legislation and regulation in Jersey relating to Money Laundering and Financing of terrorism, including the Anti Money Laundering (AML), Countering the Financing of Terrorism (CFT), and Countering Proliferation Financing (CPF) Codes of practice issued under the supervisory bodies law for Trust Company Business, Fund Service Business, Alternative Investment Funds, and Certified Funds.
• The relevant Handbooks for the Prevention and Detection of Money Laundering, the Financing of Terrorism and the countering of Proliferation Financing.
• You must have an awareness of your personal obligations and those of the relevant persons under the laws mentioned above as well as the Terrorism Law, the Directions Law, Terrorist Sanctions Measures

What you will get in return:

• A genuinely unique opportunity to be part of an expanding large global business;
• Competitive remuneration commensurate with skills and experience.
• Training and development opportunities

Disclaimer: Unsolicited CVs sent to Apex (Talent Acquisition Team or Hiring Managers) by recruitment agencies will not be accepted for this position. Apex operates a direct sourcing model and where agency assistance is required, the Talent Acquisition team will engage directly with our exclusive recruitment partners.

Implement the compliance strategy aligned to the compliance monitoring plan to assist the client business in honouring their responsibility to comply with applicable regulatory requirements through directing the compliance function through identification, assessing, managing, monitoring and report on regulatory compliance risks facing the organisation.

This position shall further provide assurance that company policies and procedures are being complied with and that the organisation meets the regulatory and company's own standards and ensure that compliance support is aligned to business strategy.

Prudential Authority Specific Responsibilities:

• Ensure compliance with regulations issued by the Prudential Authority.

• Stay abreast of Prudential Authority directives and guidelines relating to non-life insurers.

• Monitor compliance with Prudential Authority requirements.

• Prepare and submit Prudential Authority notifications, applications and reports.

• Provide guidance to business and assist with implementation of compliance policies and projects.

• Drafting and compiling regulatory submissions.

Qualifications:

• LLB, Legal or Compliance qualification.

• Successfully passed the Key Individual Regulatory Examination 1 as required by the FSCA for Licensed Compliance Officers

• Phase I Approved - Category I FAIS Licensed Compliance Officer would be advantageous

• Post Graduate Diploma in Compliance Management would be advantageous

• Risk Qualifications will also be an advantage

Experience:

• At least 5 years' Compliance experience in the financial services industry

• 2nd line compliance experience

• In depth knowledge of legislation relating to non-life insurers, including Financial Sector Regulation Act.

• On-site meetings and engagements with Regulators.

Experience that will be advantageous:

• Combined assurance planning and execution

• 1st line compliance experience

Regulatory Complaints Handling

Job Type: Full-time

Pay: R67 000,00 - R70 000,00 per month

Application Question(s):

• Are you a registered compliance officer with the FSCA
• Have you dealt with Regulatory authorities and for how many years
• Do you have a LLB

Work Location: In person

Business Unit: Discovery Bank

Function: Banking

Date: 16 Sept 2025

About Discovery

Discovery's core purpose is to make people healthier and to enhance and protect their lives. We seek out and invest in exceptional individuals who understand and support our core purpose, and whose own values align with those of Discovery. Our fast-paced and dynamic environment enables smart, self-driven people to be their best. As global thought leaders, Discovery is passionate about innovating in order to not only achieve financial success, but to ignite positive and meaningful change within our society.

About Discovery Bank

Discovery Bank is a bank like no other – a shared-value bank, designed with our clients in mind. We are all about sharing the value that clients create when they manage their money well, back with them through exceptional interest rates and rewards. Our Vitality Money programme measures how well clients manage their finances, informs them of what it means to be financially healthy, and empowers them with the knowledge to get enhanced rewards for managing their money well. If you are adaptable, a problem-solver, always questioning the way things are done, passionate about doing what is right, and obsessed with providing a quality service experience, we have a job for you where you can be your best in an environment that's safe and nurturing.

Job Purpose

The Regulatory Compliance Specialist develops, implements and oversees the regulatory compliance strategies of the bank. Assists in the establishment of an effective compliance function, framework and core processes for the bank.

Areas of responsibility may include but not limited to

• Provide Compliance advice and guidance to business and key stakeholders
• Initiates and assists in the development of key compliance policies and standard operating procedures
• Ensures that these policies and procedures are consistent with the approvals of various boards
• Identifies and assists with training and educational needs regarding compliance practices and make recommendations and develop training content
• Ensures compliance with industry regulatory standards
• Implements core Compliance principles, frameworks, processes, systems and platforms
• Implements Compliance Risk Management Framework, reviews Regulatory Universe and implementation of the Compliance Risk Management Plans and control gap analysis.
• Compiles and assists with compliance reports for Management and relevant Bank committees.
• Assists with Regulator and Audit reviews and oversee compliance actions.
• Assist with Regulatory Change and commentary processes in Discovery Bank.
• Register and maintain breaches and incidents.

Skills

Required:

• Have an understanding of and an ability to implement Compliance governance
• Have an understanding of the legislative and regulatory requirements impacting the South African Banking Sector
• Have detailed knowledge of the legislative and regulatory environment and reporting requirements imposed by South African Regulators (SARB, FSCA and NCR) specifically, but not limited to, the Banks Act, FAIS, NCA, CPA and Conduct Standards for Banks.

Preferred:

• Microsoft word, excel and power point.

Qualifications

Required:

• A Legal degree, a Bachelors degree and or a compliance qualification
• Have an understanding of the core principles of an effective Compliance function.

Work Experience

Required:

• At least 5 years Compliance experience in the financial services industry.

Preferred:

• Retail Banking experience advantageous

EMPLOYMENT EQUITY

The Company's approved Employment Equity Plan and Targets will be considered as part of the recruitment process. As an Equal Opportunities employer, we actively encourage and welcome people with various disabilities to apply.

Make an impact with NTT DATA

Join a company that is pushing the boundaries of what is possible. We are renowned for our technical excellence and leading innovations, and for making a difference to our clients and society. Our workplace embraces diversity and inclusion – it's a place where you can grow, belong and thrive.

Your day at NTT DATA

The Associate Regulatory Compliance Analyst is an entry level role, responsible for playing a support role in the organization's efforts to comply with various international and/or regional laws, regulations, and industry standards relevant to the IT sector.

This role provides valuable assistance to the broader regulatory compliance team and gains practical experience in regulatory compliance activities.

This role supports with research and monitoring activities and assists in the development and implementation of regulatory compliance policies, procedures and processes.

An Associate Regulatory Compliance Analyst is instrumental in assisting the company with adhering to regulatory requirements and industry standards, ensuring that it operates within the bounds of applicable laws and regulations while minimizing legal risks and promoting ethical conduct.

This role works under the supervision of a manager or more experienced team member.

Key responsibilities:

• Conducts research on global and regional laws, regulations, and industry standards affecting the IT industry.
• Stays updated on regulatory changes and their potential impact on the company.
• Assists in the preparation and maintenance of compliance documentation and reports for internal and external stakeholders (may include regulatory filings, audit reports, and compliance records).
• Supports compliance monitoring activities by assisting in tracking compliance initiatives, conducting basic internal audits, and ensuring documentation is up to date.
• Assists in the review and updating of compliance policies, procedures, and guidelines to ensure alignment with legal and regulatory requirements.
• Maintains accurate records and databases related to compliance activities, including compliance training records and incident logs.
• Participates in compliance training programs to develop an understanding of compliance standards, regulations, and best practices.
• Contributes to the identification of potential compliance risks and vulnerabilities.
• Assists in the development of mitigation plans to cover potential risks and vulnerabilities.
• Assists in reviewing contracts, agreements, and partnerships for compliance with legal and regulatory obligations, focusing on basic contract terms.

To thrive in this role, you need to have:

• Familiarity with legal and regulatory frameworks relevant to the IT industry, including data protection laws, export controls, and industry-specific regulations.
• Analytical skills to interpret and apply complex legal and regulatory requirements.
• Effective written and verbal communication skills to convey compliance information to team members and stakeholders.
• Attention to detail to ensure accurate documentation and adherence to compliance standards.
• Ability to collaborate effectively with cross-functional teams and stakeholders.
• Aptitude for identifying compliance challenges and proposing potential solutions.
• Possesses high ethical standards and integrity, with a commitment to promoting a culture of compliance and ethics.
• Has data analysis skills to assist in compliance monitoring and reporting.
• Ability to work independently or as part of a team.
• Has organizational and time management skills, together with effective planning and problem-solving skills.

Academic qualifications and certifications:

• Bachelor's degree or equivalent in law, business, compliance, or a related field.
• Relevant certifications in compliance, such as Certified Compliance and Ethics Professional (CCEP), Certified Information Systems Security Professional (CISSP), or Certified Regulatory Compliance Manager (CRCM).

Required experience:

• Entry level of knowledge of relevant laws and regulations, including data protection laws, antitrust regulations, export controls, and industry-specific regulations.
• Entry level of experience in compliance, legal, or regulatory roles within the IT industry or a related field.
• Entry level of experience with compliance auditing, reporting, and documentation.
• Entry level of experience working within a global matrixed organization, preferably within the IT services industry.

Workplace type:

Hybrid Working

About NTT DATA

NTT DATA is a $30+ billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long-term success. We invest over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure, and connectivity. We are also one of the leading providers of digital and AI infrastructure in the world. NTT DATA is part of NTT Group and headquartered in Tokyo.

Equal Opportunity Employer

NTT DATA is proud to be an Equal Opportunity Employer with a global culture that embraces diversity. We are committed to providing an environment free of unfair discrimination and harassment. We do not discriminate based on age, race, colour, gender, sexual orientation, religion, nationality, disability, pregnancy, marital status, veteran status, or any other protected category. Join our growing global team and accelerate your career with us. Apply today.

It's fun to work in a company where people truly BELIEVE in what they're doing

As Senior Legal Counsel, you will be responsible for providing strategic legal support to the Tiger Group Legal Team across regulatory advisory, compliance, litigation, and intellectual property matters. You will guide internal stakeholders on the implementation, execution, and monitoring of relevant legal and regulatory frameworks, ensuring alignment with South African and industry-specific legislation and industry standards. Under the supervision of the General Counsel, you will deliver efficient transactional legal services, manage legal risks, and contribute to the development of a strong governance and compliance culture. Your role will also include advising on advertising and marketing law, protecting and commercialising intellectual property assets, and supporting dispute resolution processes

What You Will Do

• Provide strategic legal advice across regulatory, compliance, litigation, and commercial matters.
• Conduct legal risk assessments and develop mitigation strategies in collaboration with internal stakeholders.
• Draft, review, and negotiate a wide range of commercial contracts and legal documentation.
• Advise on Intellectual Property matters, including protection, enforcement, licensing, and commercialisation of IP assets.
• Ensure compliance with advertising and marketing laws, including consumer protection regulations and industry codes.
• Monitor and interpret new and proposed legislation, assessing its impact on business operations and advising on necessary actions.
• Communicate legal developments and regulatory changes to relevant stakeholders with strategic recommendations.
• Support dispute resolution and litigation processes, including managing external counsel where necessary.
• Collaborate with internal teams to embed a culture of compliance and governance.
• Participate in industry forums and legal networks to stay abreast of emerging legal trends and best practices.
• Provide training and guidance to business units on legal and regulatory requirements.
• Continuously solicit feedback to improve legal service delivery and client satisfaction.

What You Will Bring To The Table
Competencies

• Strong understanding of South African & industry specific legal and regulatory frameworks.
• Expertise in Intellectual Property law, including protection, enforcement, and commercialization of IP assets.
• Solid grasp of advertising and marketing law, including regulatory compliance with consumer protection and industry standards.
• Ability to conduct regulatory assessments and interpret legislative impact on business operations.
• Skilled in legal research, risk analysis, and stakeholder engagement.
• Effective project management and task execution.
• High attention to detail and commitment to quality.
• Collaborative mindset with the ability to act as a trusted advisor.

Experience

• 4–5 years post-qualification experience (preferably in-house), ideally within FMCG or a similar industry.
• Generalist legal experience across Intellectual Property, Commercial Litigation, and Regulatory matters.
• Compliance experience is advantageous but not essential.

Qualification

• LLB degree (Bachelor of Laws)
• Admitted Attorney of the High Court of South Africa
• LLM in Business/Commercial Law (advantageous)

In accordance with the employment equity plan of Tiger Brands and its employment equity goals and targets, preference may be given, but is not limited, to candidates from under-represented designated groups.

Want to do the Best Work of Your Life?

Working at Signant Health puts you at the very heart of the world's most exciting sector - a high-growth, dynamic company in an extraordinary industry. We're radically changing the clinical trial landscape, driving change through the technology and innovations we create and the services we deliver to our customers.

Where do you fit in?

The Senior Technology Regulatory Compliance Analyst is responsible for ensuring compliance with global regulatory standards across Signant Health's technology functions, including Enterprise IT, Cloud Operations, and R&D. Based in South Africa, this role provides leadership and expertise in regulatory compliance, focusing on systems and processes that support internally developed software products sold within the life sciences industry and Enterprise IT solutions. Reporting to the Associate Director of Regulatory Compliance, this position collaborates with cross-functional teams to build and maintain robust compliance frameworks.

Key Responsibilities:

Regulatory Compliance Oversight:

• Lead compliance efforts for technology functions to ensure adherence to global regulatory standards, including FDA 21 CFR Part 11, GAMP 5, ICH GCP, and EMA guidelines.
• Develop, implement, and maintain compliance frameworks for Enterprise IT, Cloud Operations, and R&D.
• Provide expert advice on regulatory requirements during the development and deployment of software products.
• Ensure software products meet global regulatory requirements applicable to the life sciences industry.

Audit and Risk Management:

• Plan and lead internal audits of IT systems and processes to assess compliance readiness.
• Support external audits and inspections by regulatory authorities and customers.
• Conduct risk assessments, identify potential compliance gaps, and oversee the implementation of mitigation strategies.

Policy and Documentation Management:

• Develop, review, and update policies, SOPs, and other documentation to align with regulatory requirements.
• Ensure validation and verification processes for IT systems and software are adequately documented and maintained.

Collaboration and Cross-Functional Engagement:

• Collaborate with Enterprise IT, Cloud Operations, and R&D teams to embed compliance into system design, software development, and operations.
• Act as a liaison with external stakeholders, including auditors and regulatory bodies, to address compliance-related queries.

Training and Mentorship:

• Design and deliver training programs on regulatory compliance requirements for technology teams in India.
• Mentor and guide junior analysts to ensure consistent application of compliance principles.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance compliance processes and frameworks across technology functions.
• Stay updated on emerging trends and regulatory changes impacting the life sciences and software development industries.

Qualifications:

Education:

• Bachelor's degree in Information Technology, Computer Science, Regulatory Affairs, or a related field.
• Advanced degree or certifications (e.g., RAC, CRCP, or equivalent) preferred.

Experience:

• 5-10 years of experience in IT regulatory compliance, particularly in life sciences or software development.
• Strong experience with global regulatory frameworks, including FDA 21 CFR Part 11, GAMP 5, and ICH GCP.

Skills and Competencies:

• Comprehensive understanding of IT systems, cloud operations, and software development lifecycle (SDLC).
• Proven ability to manage audits and regulatory inspections with strong problem-solving skills.
• Excellent project management, communication, and leadership abilities.
• Experience in working with geographically dispersed teams and global stakeholders.

Preferred Qualifications:

• Familiarity with Agile and DevOps methodologies.
• Experience with compliance in cloud-based environments and data security standards.

Does this sound like
you'd like to explore
? Then we'd love to hear from you

Please apply below.

We review and respond to every application, keep an eye on your inbox for our reply.

Please note that Signant does not accept unsolicited resumes from Third Party vendors.

• Bachelor's degree in the field of regulatory/ compliance/ risk specialization or
• BSc or Bachelor in Technology (Chemistry/Engineering)
• At least 5 years experience as a regulatory compliance specialist, or similar
• 5 10 years in a chemical manufacturing plant or related process manufacturing industry.
• Must have a strong regulatory and compliance background.
• Advanced knowledge and understanding of relevant corporate governance requirements and South African Regulatory Requirements in related industries.
• Knowledge of product regulations pertaining to NSF, FDA, Halaal, Kosher, BfR, REACH, Food Safety etc.
• Advanced understanding of relevant legislation and standards (non-proliferation of explosive material, regulatory, Occupational Health and Safety Act (Act 85 of 1993), ISO 9001:2015, 14001:2015 and 45001:2018).
• Advanced understanding the Globally Harmonised System (GHS) related to (SDS, label and tremcard development, generation and other legal requirements).
• Advanced understanding of information systems that generate SDS, label and tremcards
• Good knowledge of chemical technologies Chemistry and Chemical Engineering

• Ensuring that products are developed, manufactured and distributed in a manner that meets regulatory requirements.
• Manage/conduct internal and external compliance audits aligned to registrations, local, corporate and Legal requirements.
• Managing information systems that develops and generate regulatory documents.
• Coordinating regulatory compliance requirements across the organizational structures.
• Monitoring compliance and facilitating interventions to manage risks.
• Developing and enacting regulatory compliance policies, procedures and strategies.
• Providing training in regulatory and compliance practices and procedures.
• Incident Management/Non- Conformances related to regulatory compliance.
• Keeping abreast of local and international regulatory changes, developments and impacts on Buckman's business.
• Consultation and Communication with Stakeholders
• Managing associated day-to-day expenses
• Support compliance to and minimize our risk as per the POPIA legislative requirements.
• Initiate and implement continuous improvement.
• Providing support for the generation of Safety Data Sheets (SDS), label and tremcard development.
• The incumbent in this position is key to the companys succession planning and may be given other assignments as part of ongoing developmental efforts.

Description
REGULATORY AND COMPLIANCE SPECIALIST

OPERATIONS DIVISION, HAMMARSDALE

Location: Hammarsdale, Durban, South Africa

Language(s) Requirements: English

Seniority Level: Mid-Senior Level

Employment Type: Full-Time

A Regulatory and Compliance Specialist position has become available at an international manufacturing company. This is a fast - paced but friendly environment that will suit an organized person with a great eye for detail.

This position will contribute to the success of the company by taking the responsibility to ensure compliance with the laws and regulations associated with the sale of chemical products.

Qualifications

• Bachelor's degree in the field of regulatory/ compliance/ risk specialization or
• BSc or Bachelor in Technology (Chemistry/Engineering)

Experience

• At least 5 years' experience as a regulatory compliance specialist, or similar
• 5 – 10 years in a chemical manufacturing plant or related process manufacturing industry.
• Must have a strong regulatory and compliance background.

The incumbent will be responsible for the following inter alia:

• Ensuring that products are developed, manufactured and distributed in a manner that meets regulatory requirements.
• Manage/conduct internal and external compliance audits aligned to registrations, local, corporate and Legal requirements.
• Managing information systems that develops and generate regulatory documents.
• Coordinating regulatory compliance requirements across the organizational structures.
• Monitoring compliance and facilitating interventions to manage risks.
• Developing and enacting regulatory compliance policies, procedures and strategies.
• Providing training in regulatory and compliance practices and procedures.
• Incident Management/Non- Conformances related to regulatory compliance.
• Keeping abreast of local and international regulatory changes, developments and impacts on Buckman's business.
• Consultation and Communication with Stakeholders
• Managing associated day-to-day expenses
• Support compliance to and minimize our risk as per the POPIA legislative requirements.
• Initiate and implement continuous improvement.
• Providing support for the generation of Safety Data Sheets (SDS), label and tremcard development.

Knowledge, Skills And Abilities Required

• Advanced knowledge and understanding of relevant corporate governance requirements and South African Regulatory Requirements in related industries.
• Knowledge of product regulations pertaining to NSF, FDA, Halaal, Kosher, BfR, REACH, Food Safety etc.
• Advanced understanding of relevant legislation and standards (non-proliferation of explosive material, regulatory, Occupational Health and Safety Act (Act 85 of 1993), ISO 9001:2015, 14001:2015 and 45001:2018).
• Advanced understanding the Globally Harmonised System (GHS) related to (SDS, label and tremcard development, generation and other legal requirements).
• Advanced understanding of information systems that generate SDS, label and tremcards
• Good knowledge of chemical technologies – Chemistry and Chemical Engineering

Please Note

• The incumbent in this position is key to the company's succession planning and may be given other assignments as part of ongoing developmental efforts.
• This site is a Major Hazard Installation (MHI) in terms of the MHI Regulations 2022 (GNR.2989 of 31 January 2023) of the Occupational Health and Safety Act (Act 85 of 1993)

The job calls for a highly energetic, self - driven, independent, self-motivated person with excellent problem solving and communication skills, ability to meet tight deadlines and work under pressure, work in a professional manner at all times taking ownership of ensuring they stay on top of things to limit (repetitive) failures. Candidates must possess high levels of integrity together with strong self-leadership abilities.

Equity Statement

We are committed to a diverse and inclusive workplace when recruiting internally and externally. It is company policy to promote from within wherever possible. Therefore, please be aware that internal candidates will be considered first before reviewing external applicants, provided that this supports achievement of our Employment Equity goals.

Only candidates who meet the minimum requirements will be short listed. If you have not been contacted within 3 months of the closing date of the advertisement, please consider yourself unsuccessful.

CLOSING DATE: 24 June 2025

Adcock Ingram Holdings Limited and its Subsidiaries ("we", "us") is committed to protecting and respecting your privacy. Our Privacy Notice sets out the basis on which personal information collected inter alia from you, social media, recruitment agencies and our website, will be processed by us. The Privacy notice is available on our website

One of the conditions under the Protection of Personal Information Act 4 of 2013 (POPIA) provides that candidates have the right to be informed about the collection and use of their personal information,

In the course of your application: we may

• collect personal information that may be used to identify potential professional opportunities other than the job you have applied for but of which we think might be of interest to you.
• use your Personal Information to confirm references or background checks you have provided us.
• request your consent to participate in aptitude tests or recruitment assessments.

We also use your personal information to respond to your inquiries, to verify your information and to share information with you.

Your personal information will be securely stored by the Human Capital Department and it will be retained for a period of up to 12 months as of the closure of the application procedure if your application is unsuccessful, and in case of a successful application and you are hired, your data will be transferred to your personal employee file.

By applying for this position, you consent to us processing your personal information.

We reserve the right to make an appointment. If you have not heard from us within 30 (thirty) days of the closing date, please accept that your application was unsuccessful. Correspondence will be entered into only with shortlisted candidates.

Job Purpose:

Responsible for ensuring that Genop Healthcare maintains high standards of compliance in accordance with the current ISO 13485 Standard for Medical Devices, as well as all Pharmaceutical and Cosmetics GxP Standards and other legal requirements

Reporting to:

Responsible Pharmacist

Key Job Outputs:

Assisting in the submission and final registration and/or listing of new Medical Devices with the SAHPRA, for the long-term growth and benefit of the Genop business.

Assist in the maintenance and update of all dossiers, Medical Device files and listings and any other applicable licenses (e.g. Radiation Control) for all Genop products in South Africa.

Assist to ensure that all Regulatory activities performed are following all the relevant provisions of the Medicines and Related Substances Act 101 of 1965, and any other countries' legislation where applicable.

Understand and interpret government legislation and industry codes of practice relating to Regulatory Affairs, QA and Product Surveillance in South Africa.

Providing any requested Regulatory documents or available Literature for Genop products to Port Health or Customs when requested, to ensure no delays in stock being made available for sale.

Approval of advertising and promotional materials to ensure compliance with the SA Code of Marketing Practise and any other applicable legislation and internal guidelines.

Approval of company events, meetings, grants, sponsorships and donations in line with the SA Code of Marketing Practise.

Assist with the approval of all local artwork for Genop products to ensure compliance from a Regulatory, Quality and Compliance perspective.

Assist in continuously improving the Genop Quality Management System (QMS) in line with the ISO 13485 Standard, and any other applicable GxP standards.

Assist in the release of products (Cosmetics and Medical Devices) as per the Final Product Release SOP to ensure that only high-quality products are released for sale into the market and support the Supply Chain team to ensure the timely release of quality products into the market.

Assist in co-ordinating product Recall activities when required, in collaboration with Regulatory Affairs, the Adcock DC's and the Supply Chain team.

Assist in ensuring that retention/release samples are received, checked, stored and recorded for all relevant product batches released to market.

Ensure that some QA and other relevant quality related SOPs are put in place and updated as per the renewal schedule, Co-ordinate some deviations as per the approved processes.

Assist in the implementation of the required corrective and preventative actions (CAPA) and ensure that all QA or technical related matters are solved in a timely manner.

Ensure that an effective Post Marketing Product Surveillance System is in place for Genop that is compliant with ISO 13485 & SAHPRA's requirements, and external Supplier's requirements and any other applicable Genop standards and procedures.

Ensure that all reports of Adverse Events (AEs) received are logged and submitted to the relevant heath authorities, institutions and to the global suppliers as applicable.

Manage and record all Product Quality Complaints (PQCs) or queries and customer returns, with the relevant stakeholders.

PQCs and AEs are to be trended to identify recurring issues or ineffective CAPA's.

Request and file all Post Market Clinical Follow-up (PMCF) reports from the suppliers for any identified high risk Medical Devices.

Ensure that all local AE and PQC trackers are always current and up to date.

Ensure timely response and regular follow-up for any PQC or AE reports and queries.

Ensure that the Genop "Product Quality Complaints" and the "Post-Marketing Vigilance" SOPs are in place and kept current and updated as per their renewal schedule.

Ensure full understanding and implementation of the SAHPRA Guideline on Adverse Event and Post-marketing Vigilance Reporting for Medical Devices.

Drive staff awareness of the ISO 13485 Standard and the specific requirements thereof as it relates to Medical Devices sold by Genop.

• Ensure that all medical queries received are actioned or referred to the appropriate person and responded to on time.

Core Competencies:

• Professional verbal and written communication skills.
• Ability to prioritise and work to tight deadlines.
• Problem solving and decision-making skills.
• Attention to detail.
• Ability to act with integrity when working with highly sensitive and confidential matters.
• Highest level of ethics, integrity and commitment

Closing Date: 27 October 2025

Relevant Scientific or Pharmaceutical Science Degree or Diploma.

At least 5 years' experience in the Pharmaceutical or Medical Device Industry in a Product Surveillance or RA/QA Officer position.

Medical Device and ISO 13485 experience is a distinct advantage

Experience in Product Surveillance and SA Marketing Code Compliance.