Senior 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

Cambridge, Cambridgeshire, United Kingdom

Senior Regulatory Affairs Specialist - Cambridge

At Hologic, we are committed to enabling healthier lives everywhere, every day. To deliver on that purpose, we need strong regulatory expertise that helps bring new products to market, keeps mature products compliant, and ensures our submissions, labeling, technical files, and product documentation meet global regulatory expectations.

We are looking for a Senior Regulatory Affairs Specialist to support regulatory submissions, audits, inspections, technical documentation, and product lifecycle activities for medical devices. This role is ideal for a regulatory professional with strong knowledge of US, EU, and Canadian requirements who enjoys working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international regulatory teams.

What to expect:

• 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 and maintain regulatory databases, technical files, and supporting documentation.
• Review technical data, reports, labeling, marketing materials, user manuals, and other product content for regulatory compliance.
• Support compliance with US, EU, Canadian, and international regulatory requirements.
• 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.
• Participate in internal and external audits, inspections, and investigations.
• Monitor evolving regulations, standards, and procedures, and translate changes into practical business guidance.
• Contribute to process, procedure, standard, and tracking/control system improvements.
• Partner with cross-functional teams to resolve regulatory issues and support timely product approvals.

What we expect:

• Experience in the regulated medical device industry, ideally supporting product lifecycle and regulatory compliance activities.
• Hands‑on experience with regulatory submissions, technical files, product documentation, audits, inspections, and investigations.
• Strong understanding of US FDA, EU, Canadian, ISO 13485, ISO 9001, and other applicable international regulatory requirements.
• Ability to review labeling, marketing materials, user manuals, technical documentation, and supporting data from a regulatory perspective.
• Strong technical writing, communication, interpersonal, and presentation skills.
• Good data and statistical analysis skills, with the ability to make informed recommendations.
• High attention to detail and strong judgment when evaluating regulatory issues and solutions.
• Confidence working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and global partners.
• Proficiency with Microsoft Office and confidence working with regulatory databases or tracking systems.
• A college degree or technical bachelor’s degree, preferably in a scientific, engineering, or related discipline.
• Regulatory Affairs Certification — RAC — or project management experience would be beneficial.

At Hologic, your work has purpose. You will be part of a company focused on improving health through innovation, quality, and regulatory excellence.

We are committed to making Hologic a destination for top talent. From the moment you join, we provide comprehensive training, ongoing development, and the tools and knowledge you need to succeed and grow your career.

Salary: £40,000 – £50,000 gross per year

The final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances.

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