policy manager Work, Jobs in cambridge, cam (with Salaries)

Senior Manager, Regulatory Affairs
Hologic —Cambridge
- Engineering
- Analysis skills
- Leadership
Regulatory Affairs Intelligence Director
AstraZeneca —Cambridge
- Communication skills
7d
ITSOx Control, Audit & Compliance Manager
Abcam —Cambridge
- Full-time
- Remote
- Oracle
- Master's degree
- Bachelor's degree
- Annual leave
Compliance Manager
Softwerx —Cambridge
- £50,000 - £60,000 a year
- Full-time
- Hybrid work
- IT
- Annual leave
- Employee discount
Quality Compliance Manager
Marshall of Cambridge (Holdings) Limited —Cambridge
- Full-time
- Management
- Team management
- Travel
Director, Research, Ethics and policy
AHRO Center for Academic Research —Stevenage
- £30,536.94 - £42,263.45 a year
- Full-time
- Laboratory experience
- Supervising experience
- Project management
Quick apply
2d
Health, Safety and Compliance Manager
Jesus College, Cambridge —Cambridge
- £45,121 a year
- Full-time
- Bachelor's degree
- In-person
- Sick pay
Quick apply
1d
Research Services Team Lead
Avantor —Cambridge
- Full-time
- Management
- Laboratory experience
- Microsoft Office
- Annual leave
In-house FCA Compliance Lead
Beyond Co —Newmarket
- £65,000 - £75,000 a year
- Hybrid work
- Financial services
- School
- Health & wellbeing programme
- Flexible schedule
Quick apply
2d
Trust Compliance Manager
Unity Schools Partnership —Haverhill
- £32,596 - £36,362 a year
- Full-time
- Driving
- Travel
- Organisational skills
8d
Trust Compliance Manager (Operations / Estates)
Unity Schools Partnership —Haverhill
- £32,596 - £36,362 a year
- Full-time
- Driving
- Travel
- Organisational skills
Safety, Quality and Compliance Monitoring Manager
JMC Aviation —Stansted
- Monday to Friday
- Leadership
- Annual leave
- Employee assistance programme

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Senior Manager, Regulatory Affairs

Hologic -
Cambridge

Apply Now

Job details

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!

#LI-RH1

Apply Now

Refine Your Search

policy manager jobs in cambridge, cam

Senior Manager, Regulatory Affairs

Regulatory Affairs Intelligence Director

ITSOx Control, Audit & Compliance Manager

Compliance Manager

Quality Compliance Manager

Director, Research, Ethics and policy

Health, Safety and Compliance Manager

Research Services Team Lead

In-house FCA Compliance Lead

Trust Compliance Manager

Trust Compliance Manager (Operations / Estates)

Safety, Quality and Compliance Monitoring Manager

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