QA/RA Specialist-Medical Devices

Walker Cole International is searching for a Quality Assurance (QA)/ Regulatory Affairs (RA) Specialist to join a bespoke UK-based Medical Device consultancy based in the greater London area.

As the Quality Assurance (QA)/ Regulatory Affairs (RA) Specialist, you will provide consultation and support through medical device regulations and quality requirements, by collaborating with internal and external stakeholders.

Key Responsibilities as a Quality Assurance (QA)/ Regulatory Affairs (RA) Specialist:

• Interpret and stay updated on global regulatory requirements related to medical devices, including but not limited to FDA regulations (21 CFR Part 820), EU Medical Device Regulation (MDR), ISO 13485, and other relevant standards.
• Develop, implement, and maintain quality management systems (QMS) in accordance with applicable regulatory standards.
• Provide guidance on quality control processes, including risk management, CAPA (Corrective and Preventive Actions), and complaint handling.

• Prepare and review regulatory submissions, including 510(k) applications, premarket approval (PMA) submissions, CE marking applications, and other regulatory filings.

The successful Quality Assurance (QA)/ Regulatory Affairs (RA) Specialist will have:

• Bachelor's degree in a relevant scientific or engineering field (e.g., Biomedical Engineering, Chemistry, Biology) required; advanced degree preferred.
• Significant experience in medical device regulatory affairs and quality assurance, with a demonstrated track record of successful regulatory submissions and compliance.
• In-depth knowledge of FDA regulations, EU MDR, ISO 13485, and other international regulatory requirements for medical devices.
• Certification such as RAC (Regulatory Affairs Certification) or ASQ (American Society for Quality) certification is desirable.

Quality Assurance | QA t | Quality | Quality Management System | QMS | Change control | Deviation | Corrective and Preventative Actions | CAPAs | RA | Regulatory Affairs | Consultant | Medical Device | ISO13485 | IVD | In-Vitro Diagnostics | FDA