Job Description

Regulatory Manager – Medical Devices

Location: Menlyn Maine, Pretoria, Gauteng
Employment Type: Permanent
Salary: R70,000 – R100,000 CTC per month
Reporting To: Head of Legal & Compliance
Industry: Medical Devices / Healthcare / Regulatory Affairs

An established organisation operating within the healthcare and medical device sector is seeking an experienced Regulatory Manager to lead and oversee its Regulatory Affairs function.

This is a senior-level position requiring extensive, hands-on experience within Medical Device Regulatory Affairs, including South African medical device regulations, SAHPRA requirements, product registrations, regulatory submissions, quality management systems, technical documentation and international regulatory frameworks.

The successful candidate will be responsible for developing and executing regulatory strategies that ensure ongoing compliance with applicable local and international regulations, facilitate market access and support the successful commercialisation of medical devices.

The Regulatory Manager will also provide leadership to the Regulatory Affairs team and act as a key point of engagement with regulatory authorities, industry bodies and internal stakeholders.

Minimum Requirements

Candidates must meet the following requirements:

• Minimum 5 years' experience in a senior Regulatory Affairs role within the medical device industry
• Postgraduate qualification in Regulatory Affairs, Quality Management, Medical Device Regulation or a related field
• Extensive knowledge of South African Medical Device Regulations
• Strong knowledge and practical experience dealing with SAHPRA
• Demonstrated experience with medical device product registrations
• Experience preparing, reviewing and managing regulatory submissions
• Strong understanding of Quality Management Systems (QMS)
• Experience compiling and maintaining technical documentation and technical dossiers
• Strong understanding of local and international medical device regulatory requirements.
• Experience interacting directly with regulatory authorities.
• Knowledge of global regulatory frameworks, including EU MDR and FDA requirements
• Knowledge of regulatory requirements applicable to Sub-Saharan African markets
• Experience managing multiple regulatory submissions, registrations and compliance deadlines.
• Valid driver's licence.
• Willingness to travel occasionally.

Key Responsibilities

1. Regulatory Strategy & Leadership

• Provide regulatory leadership and contribute to the achievement of the organisation's strategic objectives.
• Develop and implement the Regulatory Affairs strategy in alignment with business growth and commercial objectives.
• Provide strategic regulatory guidance to management and relevant business functions.
• Ensure Regulatory Affairs activities are conducted in accordance with applicable legislation and ethical standards.
• Identify potential regulatory risks and develop appropriate mitigation strategies.

2. Regulatory Compliance

• Ensure organisational compliance with South African Medical Device Regulations and other applicable regulatory legislation.
• Oversee the preparation, review and submission of:
  • Regulatory applications
  • Product registrations
  • Amendments
  • Renewals
  • Supporting regulatory documentation
• Ensure all required regulatory licences, permits and certifications remain current and compliant.
• Monitor changes in legislation and regulatory requirements.
• Assess the impact of regulatory changes on the organisation and its products.
• Implement appropriate compliance measures when regulatory requirements change.
• Ensure regulatory documentation is maintained in accordance with applicable quality and legal requirements.

3. Medical Device Registrations

• Manage and oversee the registration of medical devices with relevant regulatory authorities.
• Ensure registrations are completed accurately and within required timelines.
• Manage regulatory documentation required to support product registrations and approvals.
• Maintain appropriate records relating to registrations, licences, certifications and regulatory approvals.
• Support compliant and timely introduction of medical devices into relevant markets.

4. Licensing & Regulatory Authority Management

• Oversee licensing and registration activities with relevant authorities, including:
  • SAHPRA – South African Health Products Regulatory Authority
  • Department of Health (DoH)
  • ICASA
  • Other applicable regulatory authorities
• Build and maintain effective professional relationships with regulatory authorities and relevant industry bodies.
• Engage with organisations including SAHPRA, SABS, DoH, ICASA and SAMED, where applicable.
• Represent the organisation during:
  • Regulatory inspections
  • Regulatory audits
  • Official engagements
  • Regulatory authority meetings
• Coordinate responses to regulatory queries and requests for information.

5. Global Medical Device Regulations

• Maintain current knowledge of international medical device regulatory requirements.
• Monitor developments relating to:
  • EU Medical Device Regulation (EU MDR)
  • FDA requirements
  • Sub-Saharan African regulatory frameworks
  • Jurisdictions recognised or approved by SAHPRA
• Assess the implications of international regulatory developments for the organisation.
• Communicate regulatory requirements to relevant internal stakeholders.
• Provide guidance regarding regulatory compliance associated with the import, export, manufacture and distribution of medical devices

6. Technical Documentation & Regulatory Submissions

• Oversee the preparation and maintenance of regulatory documentation.
• Ensure technical dossiers and supporting documentation meet relevant regulatory requirements.
• Review regulatory documentation for completeness, accuracy and compliance before submission.
• Manage regulatory submission timelines and priorities.
• Ensure documentation remains current throughout the relevant product lifecycle.

7. Post-Market Surveillance

• Implement and oversee appropriate Post-Market Surveillance processes.
• Ensure appropriate processes are maintained for:
  • Product complaints
  • Adverse events
  • Product recalls
  • Field safety notifications
  • Trend monitoring
  • Mock recalls
• Ensure regulatory reporting and documentation obligations relating to post-market activities are appropriately managed.
• Work with relevant internal teams to address product-related regulatory matters.

8. Internal Regulatory Support

• Provide Regulatory Affairs support to internal business units.
• Work closely with Sales and Marketing teams to compile regulatory documentation required for licensing and registration.
• Support the timely registration of medical devices with relevant authorities.
• Collaborate across the organisation to facilitate compliant and timely product launches.
• Provide regulatory guidance throughout relevant stages of the product lifecycle.

9. Regulatory Training

• Develop and provide regulatory training and support to internal teams.
• Improve organisational awareness and understanding of regulatory requirements.
• Educate relevant employees regarding regulatory processes, responsibilities and best practices.
• Communicate changes in regulatory requirements to affected stakeholders.

10. Team Leadership & Management

• Lead, develop and manage the Regulatory Affairs team.
• Establish departmental objectives, goals, KPIs and performance standards.
• Monitor departmental performance against agreed objectives.
• Coach and mentor team members.
• Support succession planning and employee development.
• Foster a high-performance and compliance-focused culture.
• Manage departmental resources effectively.
• Manage the Regulatory Affairs departmental budget.
• Identify and implement opportunities to improve regulatory processes and operational efficiency.

Required Regulatory Knowledge

The successful candidate should demonstrate advanced knowledge across several Regulatory Affairs disciplines, including:

• Medical device registrations
• South African Medical Device Regulations
• SAHPRA requirements
• Regulatory submissions
• Quality Management Systems
• Technical dossiers and technical documentation
• Product approvals
• Regulatory licences and permits
• Post-Market Surveillance
• Local and international regulatory compliance
• EU MDR
• FDA regulatory requirements
• Sub-Saharan African medical device regulations

Key Competencies

Strategic Leadership

Ability to provide senior-level regulatory guidance and contribute to organisational strategy.

Regulatory Authority Engagement

Demonstrated experience interacting directly with regulatory authorities and representing an organisation during formal regulatory engagements.

Regulatory Compliance

Strong ability to interpret regulatory requirements, develop appropriate regulatory strategies and ensure compliance across different classes of medical devices.

Medical Device Regulatory Expertise

Advanced understanding of South African and international medical device regulations.

Product Registration

Strong knowledge and practical experience with product registrations across relevant regulatory authorities.

Planning & Time Management

Excellent organisational and prioritisation skills with the ability to manage multiple regulatory submissions, registrations, renewals and compliance deadlines simultaneously.

Leadership & People Management

Ability to lead, develop, coach and manage a Regulatory Affairs team while maintaining strong performance standards.

Stakeholder Management

Ability to build effective relationships with regulatory authorities, industry bodies, senior management and cross-functional teams.

Attention to Detail

High level of accuracy when reviewing technical documentation, regulatory submissions and compliance records.

Communication

Strong written and verbal communication skills with the ability to translate complex regulatory requirements into clear guidance for internal stakeholders.

Non-Negotiable Requirements

Applicants should only apply if they can demonstrate substantial alignment with the following:

• 5+ years' senior Regulatory Affairs experience within the MEDICAL DEVICE industry.
• Relevant postgraduate qualification in Regulatory Affairs, Quality Management, Medical Device Regulation or a related discipline.
• Strong practical knowledge of SAHPRA Medical Device Regulations
• Proven medical device registration experience.
• Experience preparing and/or overseeing regulatory submissions
• Experience with technical dossiers / technical documentation
• Strong understanding of Quality Management Systems
• Knowledge of both South African and international medical device regulations
• Experience engaging directly with regulatory authorities
• Ability to work from the Pretoria / Menlyn Maine office
• Valid driver's licence and willingness to undertake occasional travel.

Important Candidate Profile

This opportunity is specifically suited to an experienced Medical Device Regulatory Affairs professional

Candidates whose Regulatory Affairs experience is predominantly in unrelated industries, or who do not have substantial medical device regulatory experience, are unlikely to meet the requirements of the position.

The successful candidate must be comfortable operating at both a strategic and hands-on regulatory level — leading the function while remaining closely involved in registrations, submissions, documentation, compliance and regulatory authority engagement.

Remuneration

R70,000 – R100,000 CTC per month, depending on qualifications, experience and overall suitability.

Location

Menlyn Maine, Pretoria, Gauteng

Employment Type

Permanent