Regulatory Specialist

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 Lead and oversee design control and risk management activities for medical device and combination product development programs. Ensure design control and risk management documentation is authored, approved, and maintained in line with global regulatory and quality standards. Provide support and guidance to cross-functional teams, external design companies, and manufacturing partners. Contribute to design validation activities, including use-related risk assessments. Support the preparation of regulatory submission data and content. Assist with internal and external audits of Quality Management Systems. Ensure all activities are compliant with applicable regulations, standards, and company processes. Education, Skills, and Experience Essential Requirements BSc or MSc in a relevant science or engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering, or related). Minimum 5 years’ experience in the medical device and/or pharmaceutical combination product industry . Strong experience in design control and risk management for medical devices or combination products. In-depth knowledge of regulatory standards including: ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU MDR. Understanding of Good Manufacturing Practices (GMP) . Excellent communication skills (oral, written, and presentation). Strong attention to detail, organizational skills, and ability to manage multiple projects. Ability to work independently as well as in cross-functional teams. Valid driving license and willingness to travel when required. Desirable Skills Familiarity with Human Factors / Usability Engineering (EN 62366). Knowledge of device assembly and related manufacturing processes. Experience with standards such as EN 60601 (electrical safety) and EN 62304 (software). Experience supporting internal and external audits. What We Offer Opportunity to work on innovative drug-device combination products . Collaborative and supportive team environment. Competitive salary and benefits package. Professional growth and development opportunities.

Location: Great Abington, UK, GB

Posted Date: 9/7/2025