Job Description
Job Title:
Design Control and Risk Management Compliance Engineer
Location:
Cambridge, UK
Department:
Drug Product Design and Development (DPDD)
Reports To:
Design Control Lead
Position Summary
We are looking for a Design Control and Risk Management Compliance Engineer to join our Drug Product Design and Development team in Cambridge, UK. The role provides subject matter expertise in design control and risk management for medical device and drug-device combination product development throughout the product lifecycle. The successful candidate will ensure compliance with quality and regulatory requirements, support design validation, and collaborate closely with internal teams, external design partners, and manufacturing organizations.
Key Responsibilities
1. Lead and oversee design control and risk management activities for medical device and combination product development programs.
2. Ensure design control and risk management documentation is authored, approved, and maintained in line with global regulatory and quality standards.
3. Provide support and guidance to cross-functional teams, external design companies, and manufacturing partners.
4. Contribute to design validation acti...