Senior Regulatory Affairs Lead — Medical Devices

Hologic; Milton; On-site; GBP 40,000 - 50,000; Full time

Benefits offered by this job

Pension

Insurances

Job summary

Hologic in Cambridge, UK seeks a Senior Regulatory Affairs Specialist to support regulatory submissions, audits, and lifecycle documentation for medical devices. You will collaborate with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international teams to ensure global regulatory compliance.

Responsibilities include maintaining regulatory databases and technical files, reviewing labeling and manuals, and advising on design changes.

Qualifications

• Experience in the regulated medical device industry with lifecycle regulatory compliance.
• Hands-on with regulatory submissions, technical files, audits, inspections, and investigations.
• Strong knowledge of US FDA, EU, Canadian regulatory requirements and ISO 13485/9001.

Responsibilities

• Prepare, coordinate, and compile document packages for regulatory submissions, audits, inspections, license renewals, and annual registrations.
• Support regulatory activities for new and mature medical device products, including product changes and ongoing compliance.
• Manage regulatory databases, technical files, and supporting documentation.
• Review labeling, marketing materials, user manuals, and other product content for regulatory compliance.
• Provide regulatory input on design reviews, manufacturing changes, clinical protocols, and product approval strategies.
• Document regulatory decisions and ensure documentation remains current, accurate, and inspection-ready.
• Collaborate with cross-functional teams to resolve regulatory issues and support timely product approvals.

Skills

Regulatory submissions

Technical writing

Cross-functional collaboration

Regulatory databases

Data analysis

Attention to detail

Microsoft Office

Education

Bachelor's degree in a scientific or engineering field

Tools

Regulatory databases

Tracking systems

Job description

Hologic in Cambridge, UK seeks a Senior Regulatory Affairs Specialist to support regulatory submissions, audits, and lifecycle documentation for medical devices. You will collaborate with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international teams to ensure global regulatory compliance.

Responsibilities include maintaining regulatory databases and technical files, reviewing labeling and manuals, and advising on design changes.