Senior Medical Device Regulatory Affairs Specialist

Hologic, Inc.; Cambridge; On-site; GBP 40,000 - 50,000; Full time

Job summary

Hologic, Inc. in Cambridge, UK, is seeking a Senior Regulatory Affairs Specialist to support submissions, audits, and documentation for medical devices. You will collaborate with R&D, Quality, Clinical, and international teams to ensure regulatory compliance for US, EU, and Canadian requirements.

The role emphasizes maintaining technical files, labeling reviews, and proactive risk-based assessments, with a focus on product lifecycle activities and inspections readiness.

Qualifications

• Experience in the regulated medical device industry and product lifecycle.
• Hands-on regulatory submissions, technical files, audits, and investigations.
• Strong knowledge of US FDA, EU, Canadian requirements and ISO 13485/9001.
• Ability to review labeling, marketing materials, user manuals, and technical docs.
• Excellent technical writing, communication, and presentation skills.
• High attention to detail and sound judgment.
• Ability to collaborate with Regulatory, R&D, Clinical, Quality, Marketing.

Responsibilities

• Prepare, coordinate, and compile document packages for regulatory submissions, audits, inspections, and registrations.
• Support regulatory activities for new and mature medical device products and changes.
• Manage regulatory databases and technical files.
• Review product content for regulatory compliance across labeling and marketing materials.
• Contribute to internal/external audits, inspections, and investigations.
• Monitor evolving regulations and translate into business guidance.
• Assist cross-functional teams to resolve regulatory issues and approvals.

Skills

Regulatory submissions

Technical writing

Cross-functional collaboration

FDA US/EU/Canada knowledge

Data analysis

Attention to detail

Microsoft Office

Education

Bachelor’s degree in science/engineering

RAC certification beneficial

Tools

Regulatory databases

Microsoft Office

Job description

Hologic, Inc. in Cambridge, UK, is seeking a Senior Regulatory Affairs Specialist to support submissions, audits, and documentation for medical devices. You will collaborate with R&D, Quality, Clinical, and international teams to ensure regulatory compliance for US, EU, and Canadian requirements.

The role emphasizes maintaining technical files, labeling reviews, and proactive risk-based assessments, with a focus on product lifecycle activities and inspections readiness.