Strategic Regulatory Affairs Lead – Medical Devices

Hologic; St. Ives; On-site; GBP 40,000 - 50,000; Full time

Benefits offered by this job

Pension

Insurances

Job summary

Hologic is seeking a regulatory affairs professional to prepare and coordinate regulatory submissions, maintain technical files, and ensure compliance across US, EU, Canada and international markets. You will review labeling, marketing materials, user manuals, and product content for regulatory adherence, and support audits, inspections, and ongoing lifecycle activities.

The role requires collaboration with R&D, Quality, Marketing, and global partners, proficiency with regulatory databases, and

Qualifications

• Experience in regulated medical device industry and lifecycle support.
• Strong technical writing and ability to review labeling, data and docs.
• Familiarity with US FDA, EU, ISO 13485, ISO 9001 and international regs.

Responsibilities

• Prepare, coordinate, and compile regulatory submissions and documents.
• Review labeling, manuals, and marketing content for compliance.
• Support audits, inspections, and lifecycle regulatory activities.
• Maintain regulatory databases and technical files with accuracy.

Skills

Regulatory affairs

Technical writing

Cross-functional collaboration

Data analysis

Attention to detail

Education

Bachelor's degree in Science/Engineering

Tools

Regulatory databases

MS Office

Documentation tools

Job description

Hologic is seeking a regulatory affairs professional to prepare and coordinate regulatory submissions, maintain technical files, and ensure compliance across US, EU, Canada and international markets. You will review labeling, marketing materials, user manuals, and product content for regulatory adherence, and support audits, inspections, and ongoing lifecycle activities.

The role requires collaboration with R&D, Quality, Marketing, and global partners, proficiency with regulatory databases, and