Senior Regulatory Affairs Specialist at HOLOGIC INC

London, Essex - England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

30 Nov, 26

Salary

45000.0

Posted On

02 Nov, 26

Experience

8 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

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.
Manage labeling and unique device identification 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

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Responsibilities