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

Senior Manager, Regulatory Affairs
Hologic —Cambridge
- £71,000 - £87,000 a year
- Engineering
- Analysis skills
- Leadership
Senior People and Culture Manager
Raspberry Pi Foundation —Cambridge
- £60,000 - £66,000 a year
- Full-time
- Human resources
- Communication skills
- Annual leave
Quick apply
14d
Senior Landlord Acquisition Manager
Maxine Lester Lettings and Property Management —Saint Ives
- Up to £55,000 a year
- Full-time
- CRM software
- Business development
- Organisational skills
- Annual leave
Quick apply
6d
Senior Portfolio & Governance Manager
Cambridge University Press & Assessment —Cambridge
- £60,400 - £80,800 a year
- Full-time
- Hybrid work
- English
- Annual leave
9d
H&S Manager
Westland Horticulture Ltd —Huntingdon
- Full-time
- Communication skills
Quick apply
12d
Senior Site Manager
Keepmoat Homes —Cambridge
- Full-time
- Employee assistance programme
- Employee discount
Transport Performance & Optimisation Manager
Deanta UK Ltd —Ely
- £60,000 - £65,000 a year
- Full-time
- Microsoft Excel
- Travel
- Computer networking
- Free parking
- Annual leave
Quick apply
Training Manager
Sureserve —Newmarket
- £40,000 - £50,000 a year
- Supervising experience
- Mentoring
- In-person
- Annual leave
- Employee assistance programme
Quick apply
Head of Housing
Hundred Houses Society —Cambridge
- £62,218 a year
- Full-time
- Leadership
- Communication skills
- Negotiation
- Annual leave
- Employee assistance programme
Community Manager
Cambridge Enterprise —Cambridge
- From £45,000 a year
- Full-time
- Hybrid work
- CRM software
- Project management
- Mentoring
13h
Senior Delivery Manager
Cambridge University Press & Assessment —Cambridge
- £50,900 - £68,000 a year
- Monday to Friday
- Hybrid work
- Azure
- AWS
- Project management
- Annual leave
20h
Operational Risk Manager
WeBuyVintage —Cambridge
- £50,000 - £65,000 a year
- Full-time
- Analysis skills
- Communication skills
Quick apply
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Leadership
Senior Product Manager
RMG Digital Ltd —Cambridge
- Full-time
- Management
- Product management
- Leadership
6d
Delivery Manager (Frameworks)
M Group —Cambridge
- £58,000 - £66,000 a year
- Maintenance
- Microsoft Office
- IT
- Annual leave
- Employee assistance programme
Senior Business People Partner
Cambridge Design Partnership —Cambridge
- Hybrid work
- Human resources
Quick apply
9d
Senior Project Manager
Abcam —Cambridge
- Full-time
- Project management
- Presentation skills
- Communication skills
- Annual leave
Senior Program Manager
MathWorks —Cambridge
- Hybrid work
- Doctoral degree
- Computer Science
- Engineering
Health, Safety and Compliance Manager
Hundred Houses Society —Cambridge
- £56,485.13 a year
- Full-time
- Microsoft Excel
- Analysis skills
- Annual leave
- Employee assistance programme
6h
Program Manager
Lonza —Cambridge
- Full-time
- PMP
- Project management
- Business
14d

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Senior Manager, Regulatory Affairs

Hologic -
Cambridge

Apply Now

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, cam

Senior Manager, Regulatory Affairs

Senior People and Culture Manager

Senior Landlord Acquisition Manager

Senior Portfolio & Governance Manager

H&S Manager

Senior Site Manager

Transport Performance & Optimisation Manager

Training Manager

Head of Housing

Community Manager

Senior Delivery Manager

Operational Risk Manager

(Senior) Global Medical Director, Established Brands

Senior Product Manager

Delivery Manager (Frameworks)

Senior Business People Partner

Senior Project Manager

Senior Program Manager

Health, Safety and Compliance Manager

Program Manager

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