Legal Counsel and Regulatory Manager – Full Time – Senior Management – Reporting to CEO

The Legal Counsel and regulatory Manager will be responsible for developing and implementing policies to ensure that the organisation adheres to all relevant laws and regulations.

Key responsibilities
• Ensuring compliance with all legal and compliance requirements applicable to the company, including the countries within which it conducts its business operations
• Oversight of new product market entrants to ensure compliance with legal and regulatory requirements
• Regulatory licensing applications (product listings, amendments, renewals, research use only, registrations) with South African regulators: SAHPRA, Radiation Control and NRCS
• Regulatory licensing / registration applications throughout Africa
• Oversight of all regulatory, compliance and tender requirements for Region Africa territories
• Vigilance/adverse event/post-market surveillance management: South Africa and Africa
• Managing field notifications, and product recalls
• Ensuring compliance with/to ISO 9001 and 13485 Standards applicable to the regulatory function, including maintenance of regulatory policies, procedures and change management
• Oversee all company compliance initiatives, including POPIA, FICA, anti-bribery and corruption, ethical business practices, including training of all internal and select external stakeholders
• Maintenance of product medical device files
• Risk management and business continuity planning
• Corporate governance and overseeing compliance with Companies Act, Regulations and King IV (including oversight of Social and Ethics Committee and assisting with Employment Equity Committee)
• External stakeholder contract management
• Conducting due diligence of suppliers, distributors, and contractors
• Legal and regulatory change management, and ensuring management team is kept consistently updated regarding changes in external regulatory landscape

Experience and job requirements
Relevant post-graduate qualification (Honours-equivalent)
Interest or prior experience with/in diagnostics environment (3 years prior experience)
Understanding of quality management systems (ISO)

Skills and attributes
Strong analytical abilities
Excellent communication skills
Risk Management expertise
Ability to interpret complex legal guidelines
Attention to detail

Remuneration: R 60 000 – R 80 000

A Consultant will be in touch if you are shortlisted for the position. Please consider your application unsuccessful should you not have been contacted within 2 weeks. We will keep your CV on our database and contact you should you match the criteria of any other vacancies.