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

Senior Manager, Regulatory Affairs
Hologic —Cambridge
- £71,000 - £87,000 a year
- Engineering
- Analysis skills
- Leadership
Head of Quality - Complex Specialist Learning Disabilities Division
Glenholme Healthcare Ltd —Peterborough
- £65,000 - £85,000 a year
- Weekend availability
- Hybrid work
- Travel
- Leadership
- Paid training
- Annual leave
Quick apply
Credit Risk Manager
Fleet Assist —Huntingdon
- £40,000 a year
- Full-time
- Microsoft Excel
- Data analysis skills
- Maths
- Free parking
- Health & wellbeing programme
Quick apply
13d
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
7d
Commissioning General Manager
Aiyara Partners —Peterborough
- £65,000 - £80,000 a year
- Full-time
- Organisational skills
- In-person
- Leadership
Quick apply
14d
Operational Excellence Lead
Jensten Group —Huntingdon
- Remote
- Customer service
- Travel
- Leadership
- Annual leave
- Employee discount
Quick apply
6d
Senior Commercial Manager
AMFresh —Alconbury
Quick apply
Product Development Manager
Monkfield Reptile —Ely
- Full-time
- Engineering
- Project management
- Bachelor's degree
- Work from home
- Employee discount
Quick apply
6d
Global Product Manager - Protective Coatings Platform
U-POL Limited —Wellingborough
- Business development
- Project management
- Product management
Quick apply
Senior Commercial Manager
Howden Group Holdings —Peterborough
- Full-time
- Hybrid work
- Analysis skills
- Negotiation
Senior Registered Manager
Keys Group —Wisbech
- £55,000 - £60,000 a year
- Driving
- Annual leave
- Employee assistance programme
Quick apply
Senior Assessment Manager
Cambridge University Press & Assessment —Cambridge
- £45,100 - £60,400 a year
- Hybrid work
- English
- Project management
- Accounting
- Annual leave
12d
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 Specialist, Sustainability Advisory & LCA
Faerch Group —Ely
- Call to connect
- In-person
Quick apply
3d
Senior Proposal Manager
VCLS —Cambridge
- Full-time
- Remote
- AI
Quick apply
Risk & Compliance Manager
Jensten Group —Huntingdon
- Remote
- Annual leave
- Employee discount
Quick apply
13d
Senior Design Manager
Kier Group —Wellingborough
- Full-time
- Communication skills
R&D Operations Lead
Accora —Orwell
- £60,000 - £85,000 a year
- Full-time
Quick apply
Senior Offset/Industrial Cooperation Manager
Marshall of Cambridge (Holdings) Limited —Cambridge
- Full-time
- Hybrid work
Operations Manager
Salutem Care & Education —Cambridge
- £51,000 a year
- Management
- Travel
- SharePoint

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senior manager, regulatory affairs jobs near abbots ripton, cam

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

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Refine Your Search

senior manager, regulatory affairs jobs in abbots ripton, cam

Senior Manager, Regulatory Affairs

Head of Quality - Complex Specialist Learning Disabilities Division

Credit Risk Manager

People Operations Manager

Commissioning General Manager

Operational Excellence Lead

Senior Commercial Manager

Product Development Manager

Global Product Manager - Protective Coatings Platform

Senior Commercial Manager

Senior Registered Manager

Senior Assessment Manager

Senior Assessment Manager, Sciences

Senior Specialist, Sustainability Advisory & LCA

Senior Proposal Manager

Risk & Compliance Manager

Senior Design Manager

R&D Operations Lead

Senior Offset/Industrial Cooperation Manager

Operations Manager

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