Affairs manager Work, Jobs in Soham, Cam (with Salaries)

Senior Manager, Regulatory Affairs
Hologic —Cambridge
- £71,000 - £87,000 a year
- Engineering
- Analysis skills
- Leadership
Senior Specialist, Sustainability Advisory & LCA
Faerch Group —Ely
- Call to connect
- In-person
Quick apply
7d
Clinical Study Manager
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Project management
- Machine learning
- Annual leave
- Life insurance
Quick apply
1d
Regulatory Affairs Systems and Data Manager
Mundipharma —Cambridge
- Full-time
- Hybrid work
- Communication skills
Senior Manager, Market Access Specialty Care
Sobi —Cambridge
- Full-time
- Remote
- Doctoral degree
- English
- Master's degree
Quick apply
Medical Affairs Assistant
OGT —Cambridge
- Laboratory experience
- Master's degree
- Bachelor's degree
- Employee discount
Quick apply
Medical Affairs Scientist
OGT —Cambridge
- Laboratory experience
- Bachelor's degree
- Organisational skills
- Employee discount
Quick apply
Medical Affairs QC Analyst
OGT —Cambridge
- Laboratory experience
- Master's degree
- Bachelor's degree
- Employee discount
Quick apply
Sustainability Data Manager
British Antarctic Survey —Cambridge
- £46,444 - £51,088 a year
- Microsoft Excel
- Engineering
- Data analysis skills
- Employee discount
Corporate Tax Manager
RSM UK —Cambridge
- Full-time
- Hybrid work
- Tax experience
Private Client Tax Manager
BDO —Cambridge
- Full-time
- Microsoft Office
- Tax experience
Private Client Tax Assistant Manager
BDO —Cambridge
- Full-time
- Microsoft Office
- Tax experience
Clinical Site Technical Support Associate
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Machine learning
- IT
- Annual leave
- Life insurance
Quick apply
Shift Manager
Fish 'n' Chick'n Cambridge —Cambridge
- £12.71 - £13.71 an hour
- Full-time
- Employee discount
Quick apply
4d
Manager, Private Client Tax
Deloitte —Cambridge
- Hybrid work
Team Member
Fish 'n' Chick'n Cambridge —Cambridge
- £8.00 - £12.71 an hour
- Part-time
- Employee discount
Quick apply
4d
Team Member
Churchill's Bar Hill —Bar Hill
- £8.00 - £12.71 an hour
- Part-time
- Employee discount
Quick apply
1d
Corporate Tax Associate Director
RSM UK —Cambridge
- Full-time
- Hybrid work
- Business development
- Tax experience
M&A Tax Associate Director
RSM UK —Cambridge
- Full-time
- Hybrid work
- Business development
- Project management
- Tax experience
M&A Tax Manager
RSM UK —Cambridge
- Full-time
- Hybrid work
- Business development
- Tax experience

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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

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Refine Your Search

affairs manager jobs in soham, cam

Senior Manager, Regulatory Affairs

Senior Specialist, Sustainability Advisory & LCA

Clinical Study Manager

Regulatory Affairs Systems and Data Manager

Senior Manager, Market Access Specialty Care

Medical Affairs Assistant

Medical Affairs Scientist

Medical Affairs QC Analyst

Sustainability Data Manager

Corporate Tax Manager

Private Client Tax Manager

Private Client Tax Assistant Manager

Clinical Site Technical Support Associate

Shift Manager

Manager, Private Client Tax

Team Member

Team Member

Corporate Tax Associate Director

M&A Tax Associate Director

M&A Tax Manager

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