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

Senior Manager, Regulatory Affairs
Hologic —Cambridge
- £71,000 - £87,000 a year
- Engineering
- Analysis skills
- Leadership
Chief Operating Officer (COO)
Trade Mastermind Limited —Peterborough
- £150,000 - £200,000 a year
- Full-time
- Management
- Sales
- In-person
Quick apply
H&S Manager
Westland Horticulture Ltd —Huntingdon
- Full-time
- Communication skills
Quick apply
10d
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
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
11d
Senior Business Growth 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
3d
Senior Project Manager
Huntingdonshire District Council —Huntingdon
- £49,641 - £55,624 a year
- Full-time
- Hybrid work
- Management
- No degree
- Flexitime
Senior Portfolio & Governance Manager
Cambridge University Press & Assessment —Cambridge
- £60,400 - £80,800 a year
- Full-time
- Hybrid work
- English
- Annual leave
6d
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
Senior Delivery Manager
MaPS —Bedford
- £83,000 a year
- Hybrid work
- Continuous improvement
- Leadership
- Annual leave
- Employee assistance programme
21h
Strategic Business Support Manager (Part Time 18.5hrs)
Cambridgeshire County Council —Alconbury
- £46,956 - £50,157 a year
- Part-time
- Leadership
- Communication skills
- Annual leave
- Employee discount
5h
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Leadership
14d
Strategy and Regulation Manager (Sustainable abstraction)
Anglian Water Services Ltd —Cambridge
- From £50,000 a year
- Full-time
- Analysis skills
- Presentation skills
- Bachelor's degree
- Annual leave
Senior Quantity Surveyor (Subcontract manager)
M Group —Saint Ives
- Travel
- Annual leave
- Employee assistance programme
Senior Project Manager
Abcam —Cambridge
- Full-time
- Project management
- Presentation skills
- Communication skills
- Annual leave
Senior Product Manager
MaPS —Bedford
- £75,000 a year
- Hybrid work
- Annual leave
- Employee assistance programme
13d
Mobilisation Manager
Abacus Care & Support —Letchworth
- £40,000 - £45,000 a year
- Full-time
- Project management
- Organisational skills
- In-person
- Annual leave
Quick apply
14d
Senior Product Manager
RMG Digital Ltd —Cambridge
- Full-time
- Management
- Product management
- Leadership
4d
Head of Housing
Hundred Houses Society —Cambridge
- £62,218 a year
- Full-time
- Leadership
- Communication skills
- Negotiation
- Annual leave
- Employee assistance programme
13d
Service Manager (MSK Cambs & Peterborough)
East of England Community Health and Care NHS Trust (Cambridgeshire) —Saint Ives
- £57,528 - £64,750 a year
- Full-time
- Management
- Leadership
- Communication skills
13d

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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 grafham, cam

Senior Manager, Regulatory Affairs

Chief Operating Officer (COO)

H&S Manager

People Operations Manager

Senior People and Culture Manager

Senior Business Growth Manager

Senior Project Manager

Senior Portfolio & Governance Manager

Transport Performance & Optimisation Manager

Senior Delivery Manager

Strategic Business Support Manager (Part Time 18.5hrs)

(Senior) Global Medical Director, Established Brands

Strategy and Regulation Manager (Sustainable abstraction)

Senior Quantity Surveyor (Subcontract manager)

Senior Project Manager

Senior Product Manager

Mobilisation Manager

Senior Product Manager

Head of Housing

Service Manager (MSK Cambs & Peterborough)

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