Quality and Regulatory Affairs Specialist- Medicines and Medical Devices - Sandton - Solventum Corporation

Description

Quality and Regulatory Affairs Specialist - Medicines and Medical Devices

Solventum enables better, smarter, safer healthcare to improve lives. We pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best.

The Quality and Regulatory Affairs Specialist will play an important role in ensuring compliance with established quality principles and promote continuous improvements to productivity, quality, and customer satisfaction.

• Compile, submit and maintain dossiers for Medicines and Medical Device registration in SA and SADC countries
• Manage changes and/or emerging regulations
• Maintain ISO 13485:2016 Certification
• Develop and manage SOPs, WIs
• Handle Customer Complaints, FSCA, Adverse Events and Recalls
• Manage Vendors/Suppliers and Channel Partners
• Host Internal and external audits

To be successful in this role, Solventum requires (at a minimum) the following:

• Strong knowledge of SA and SSA Regulatory Landscape – Legislations, Regulations and guidelines
• Qualified Pharmacist registered with South African Pharmacy Council
• Experience in MedTech industry. Wound care products knowledge is an added advantage
• Bachelor Degree or higher in Pharmacy
• ISO 13485:2016 QMS experience

This role is based in Johannesburg, South Africa. It involves hybrid work arrangements, allowing for some remote work but requiring travel to the on-site office around 3 days per week.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. We are an equal opportunity employer and value diversity at our company.