Regulatory Affairs Specialist (m/f/x)

About the role

Solventum, formerly 3M Health Care, is hiring a Regulatory Affairs and Quality Compliance Specialist for its Systagenix Wound Management business in South Africa. The role is deputy responsible pharmacist and quality management representative, ensuring compliance with local regulatory and quality requirements, and managing and overseeing all regulatory and quality projects for South Africa and Sub-Saharan countries. The position is hybrid, based in Fourways, with limited domestic travel of 5-10%.

Key responsibilities

• Secure all applicable regulatory licences and certificates, and keep them valid through annual retention, amendments, rebranding and renewals.
• Maintain real-time monitoring of the regulatory landscape and track legislative and regulatory changes across internal systems and regulatory authority websites.
• Lead regulatory projects supporting product registration and listing, and suggest and test technical and regulatory ideas.
• Support the maintenance of Solventum SA's ISO 13485:2016 certification and manage external audits, including audits of channel partners and third-party distribution centres.
• Ensure timely reporting of complaints and adverse events in line with internal procedures and regulatory requirements.
• Support export-model, rebranding, DC separation and other spin-off projects, as well as bids and tenders.

Required profile

• Bachelor's degree or higher in Pharmacy.
• Minimum 2 years' experience in medicines registration.
• Minimum 5 years' experience in quality assurance.
• Registered pharmacist (with SAPC).
• Legally authorised to work in the country of employment without a work visa sponsorship.