Senior manager, regulatory affairs Work, Jobs in Cambridge, Eng (with Salaries)

Senior Manager, Regulatory Affairs
Hologic —Cambridge
- £71,000 - £87,000 a year
- Engineering
- Analysis skills
- Leadership
Senior Assessment Manager, Sciences
Cambridge University Press & Assessment —Cambridge
- £45,100 - £60,400 a year
- Hybrid work
- English
- Classroom experience
- Time management
- Annual leave
Senior Assessment Manager
Cambridge University Press & Assessment —Cambridge
- £45,100 - £60,400 a year
- Hybrid work
- English
- Project management
- Accounting
- Annual leave
14d
Regulatory Affairs Systems and Data Manager
Mundipharma —Cambridge
- Full-time
- Hybrid work
- Communication skills
Senior Offset/Industrial Cooperation Manager
Marshall of Cambridge (Holdings) Limited —Cambridge
- Full-time
- Hybrid work
Senior Process Manager
New Global Vision Ltd —Cambridge
- £65,000 - £68,000 a year
- Full-time
- Microsoft Office
- Analysis skills
- Continuous improvement
- Free parking
- Health & wellbeing programme
Quick apply
12d
People Operations Manager
Malary Ltd —Cambridge
- £45,000 - £50,000 a year
- Full-time
- Microsoft Office
- Analysis skills
- Human resources
- Free parking
- Annual leave
Quick apply
8d
Senior Manager, Programs Group - 751
Quantinuum —Cambridge
- Full-time
- Doctoral degree
- Computer Science
- Master's degree
- Annual leave
Senior Product Manager
Cambridge University Press & Assessment —Cambridge
- £49,300 - £65,950 a year
- Hybrid work
- Annual leave
12d
Insight Application Manager
Cambridge University Press & Assessment —Cambridge
- £38,300 - £53,600 a year
- Hybrid work
- English
- Teaching
- Annual leave
8d
Senior Program Manager
MathWorks —Cambridge
- Hybrid work
- Doctoral degree
- Computer Science
- Engineering
13d
Operations Manager
Salutem Care & Education —Cambridge
- £51,000 a year
- Management
- Travel
- SharePoint
R&D Operations Lead
Accora —Orwell
- £60,000 - £85,000 a year
- Full-time
Quick apply
Senior Proposal Manager
VCLS —Cambridge
- Full-time
- Remote
- AI
Quick apply
Senior Biological Scientist
Owlstone Medical Ltd —Cambridge
- Full-time
- Doctoral degree
- Master's degree
- In-person
- Free parking
- Health & wellbeing programme
Quick apply
12d
Medical Science Liaison - South England
Alexion Pharmaceuticals,Inc. —Cambridge
- Project management
- Bachelor's degree
- Travel
12d
Senior Project Manager
Abcam —Cambridge
- Full-time
- Project management
- Presentation skills
- Communication skills
- Annual leave
11d
Senior Delivery Manager
Cambridge University Press & Assessment —Cambridge
- £50,900 - £68,000 a year
- Hybrid work
- Continuous improvement
- Agile
- Leadership
- Annual leave
7d
Senior Manager Operations
FedEx EU —Stansted
- Full-time
- Continuous improvement
- Communication skills
1d
Scientific Communications and Engagement Lead
Cycle Pharmaceuticals —Cambridge
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Gym membership
- Flexible schedule

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senior manager, regulatory affairs jobs near cambridge, eng

Senior Manager, Regulatory Affairs

Hologic -
Cambridge

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Job details

£71,000 - £87,000 a year

Benefits

Company pension

Qualifications

Engineering
Analysis skills
Leadership
Communication skills
FDA regulations

Full job description

Senior Manager, Regulatory Affairs

At Endomag, a Hologic company, we are driven by a clear purpose: advancing health through innovative medical technologies that improve and save lives. We are seeking an experienced Senior Manager, Regulatory Affairs to lead the Regulatory function at our Cambridge site.

In this leadership role, you will oversee regulatory activities across a portfolio of innovative and established products. You will guide regulatory strategy, lead a high‑performing team, and partner with global and cross‑functional stakeholders to support product development, market access, and regulatory compliance.

What To Expect:

Lead the Regulatory Affairs function at the Cambridge site and provide direction to the local regulatory team.
Develop and execute regulatory strategies for new product development and existing products, aligned with global regulatory requirements and company policies.
Drive regulatory submissions including pre‑clinical submissions, clinical trial applications, and marketing authorizations to support timely approvals.
Provide strategic regulatory guidance to cross‑functional teams and translate regulatory requirements into practical development plans.
Partner with divisional and senior leadership to align regulatory priorities with business and product development goals.
Build and maintain relationships with regulatory authorities and represent the company in submissions, audits, and regulatory discussions.
Support New Product Development programs, ensuring regulatory considerations are integrated throughout the product lifecycle.
Oversee regulatory compliance for marketed products and support lifecycle management activities.
Ensure product development and design changes comply with FDA Quality System Regulation, ISO 13485, and other applicable standards.
Support regulatory aspects of clinical studies required for regulatory approvals.
Mentor and develop regulatory team members while managing regulatory priorities, timelines, and resources.
Monitor regulatory developments and industry trends to inform regulatory strategy.

What We Expect:

Degree in engineering or a scientific discipline; biomedical engineering preferred.
Significant Regulatory Affairs experience within the medical device or similarly regulated industry.
Proven success managing regulatory submissions and compliance for medical devices; experience with combination products is advantageous.
Experience interacting with regulatory authorities and supporting approvals in the US and EU.
Strong knowledge of FDA regulations (21 CFR), ISO 13485, EU MDD/MDR, and global medical device regulatory frameworks.
Solid understanding of medical device Design Controls and Risk Management.
Demonstrated leadership experience in a matrixed organization.
Strong analytical, communication, and stakeholder management skills.
Ability to manage multiple priorities in a fast‑paced, collaborative environment.

Why Join Hologic?

Make a Difference: Impact millions of lives by ensuring the highest standards in women’s health.
Grow Your Career: Thrive in a global, innovative, and supportive environment.
Drive Change: Be part of a company that values your ideas, expertise, and leadership.

Ready to make your mark? Apply now to lead regulatory excellence at Hologic!

Salary: £71,000 – £87,000 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.

#LI-RH1

Apply Now

Refine Your Search

senior manager, regulatory affairs jobs in cambridge, eng

Senior Manager, Regulatory Affairs

Senior Assessment Manager, Sciences

Senior Assessment Manager

Regulatory Affairs Systems and Data Manager

Senior Offset/Industrial Cooperation Manager

Senior Process Manager

People Operations Manager

Senior Manager, Programs Group - 751

Senior Product Manager

Insight Application Manager

Senior Program Manager

Operations Manager

R&D Operations Lead

Senior Proposal Manager

Senior Biological Scientist

Medical Science Liaison - South England

Senior Project Manager

Senior Delivery Manager

Senior Manager Operations

Scientific Communications and Engagement Lead

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