Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Lead

Salary: Competitive and will depend on experience

There is a specific need for the candidate to have experience within software development standards, in particular IEC 62304, IEC 62366 and with SaMDs.

• Quality Management System: Implement, maintain, and improve a comprehensive QMS in accordance with relevant quality standards (e.g., ISO 13485, MDSAP).
• Regulatory Compliance: Stay updated on global regulatory requirements (e.g., FDA, EU MDR, UK MDR) and ensure timely and compliant submissions for product approvals, licence renewals etc.
• Quality Assurance: Oversee quality assurance processes, including design controls, risk management, verification and validation activities.
• Audits and Inspections: Coordinate and manage internal audits, lead external audits and regulatory inspections, and drive continuous improvement initiatives.

• Bachelor’s degree or higher in a relevant scientific discipline.
• Minimum of 5 years of experience in quality assurance and regulatory affairs roles within the medical device industry.
• In-depth knowledge of QMS standards (e.g., ISO 13485, MDSAP), medical device regulations (e.g., FDA, EU MDR, UK MDR, Health Canada), and software development lifecycle methodologies.
• Strong understanding of risk management principles, design controls, verification and validation processes, post-market surveillance, and vigilance requirements for medical devices.
• Proven experience in preparing and submitting regulatory filings, managing regulatory interactions, and facilitating successful product approvals.

If you are a dedicated and experienced QA/RA professional with a passion for ensuring the quality and regulatory compliance of innovative medical devices, we encourage you to apply for this exciting opportunity via the link.