Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Lead

Location: Hybrid – need to be able to attend the Cambridge siteHours: 37.5 hoursSalary: Competitive and will depend on experience

Reed Scientific have partnered with an industry leading Biotech at the forefront of diabetes research. My client has an immediate requirement for someone to lead the quality and regulatory projects and functions. You will maintain and improve robust quality management systems and ensure adherence to regulatory requirements throughout the development lifecycle of our medical device products. There is a specific need for the candidate to have experience within software development standards, in particular IEC 62304, IEC 62366 and with SaMDs.

Key Responsibilities

• 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.

Qualifications and Experience

• 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.