Quality and Regulatory Affairs Manager

Quality and Regulatory Affairs Manager focuses on leading the development, maintenance and improvement of the qms in line with applicable standards and regulations.

What the role involves

• Leading the development, maintenance and improvement of the QMS in line with applicable standards and regulations.
• Provide quality and regulatory input into technology and product development activities.
• Supporting requirements capture, standards interpretation, clinical evaluation and documentation.
• Driving hazard analysis, risk management and quality documentation activities.
• Maintain technical documentation and medical device file content where required.
• Supporting interactions with notified bodies and regulatory authorities.

Skills and requirements

• Experience with US FDA regulations, 21 CFR 820 and/or 21 CFR 11.
• Experience working under EU MDR Article 10(9) or within a medical device QMS.
• Experience with structured problem-solving methodologies such as 8D.
• Experience supporting CE marking and ISO 13485 certification.

Known job details

• Pay: £55,000–£75,000