Regulatory CMC Manager, Devices

Role Summary

Regulatory CMC Manager, Devices to lead global device-related regulatory strategies and lifecycle management for medical devices and drug-device combinations. You will collaborate across cross-functional teams to ensure design, development, and lifecycle management meet global regulatory requirements, and contribute to innovations that improve patient outcomes. Location: United Kingdom (Ware, London, Stevenage) or United States (Durham Blackwell Street or Upper Providence) with hybrid working.

Responsibilities

• Develop and implement regulatory device strategies to support product development, registration, and lifecycle management.
• Collaborate with cross-functional teams, including technical, regulatory, manufacturing, clinical and quality, to ensure device-related deliverables meet global standards.
• Provide interpretation and advice on regulatory guidance on device design, development, and compliance.
• Identify and manage device-related regulatory risks and develop mitigation strategies and communication to ensure project submission success.
• Support major inspections and audits related to device development and manufacturing from a regulatory strategy perspective.
• Proactively look to continuously improve processes and systems to enhance efficiency and quality in device-related regulatory activities.

Qualifications

• Required: Bachelor’s degree (or equivalent) in engineering, life sciences, or a related field.
• Required: Detailed experience in medical device and combination product development, manufacturing, or regulatory affairs.
• Required: Good knowledge of global medical device regulations and standards.
• Required: Strong project management and organizational skills.
• Required: Ability to collaborate effectively in cross-functional teams.
• Required: Excellent communication and problem-solving skills.
• Preferred: Advanced degree (Master’s or PhD or equivalent) in engineering, life sciences, or a related field.
• Preferred: Development experience ideally including previous roles within drug-device combination or vaccine products.
• Preferred: Competent with risk management processes for medical devices.
• Preferred: Experience working with external partners or suppliers.
• Preferred: Proven ability to lead and mentor teams.
• Preferred: Knowledge of emerging trends and technologies in medical devices and combination products.
• Preferred: Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
• Preferred: Appreciation of aseptic processing, device testing, human factor verification and validation, notified body opinions, and design control quality management systems.