Regulatory affairs lead Work, Jobs in Harmondsworth, Gtl (with Salaries)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
12d
Northern Europe Regulatory Affairs Director
Kenvue —Reading
- Hybrid work
- English
- Analysis skills
- Bachelor's degree
Nutrition Specialist (Global Regulatory & Corporate Affairs)
Oatly AB —London
- Part-time
- Hybrid work
- English
- Master's degree
- Travel
Quick apply
Global Value, Access & Government Affairs Lead
Mundipharma —London
- Full-time
- Doctoral degree
- Master's degree
- Business development
Patient-Centered Outcomes Research (PCOR) Lead (UK)
UCB —Slough
- Doctoral degree
- Master's degree
- Leadership
8d
Head of Regulatory Affairs - AI and P2P (100% remote)
Tether Operations Limited —London
- Full-time
- Remote
- Computer Science
- Public speaking
- English
Lead, Licensing & Regulatory Affairs - Africa, Amazon Leo Global Licensing - EMEA
Amazon Kuiper Services Europe SARL, UK Branch —London
- Full-time
- Engineering
- Analysis skills
- Bachelor's degree
Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed
PrimeVigilance —Guildford
- Full-time
- Remote
- Nursing
- English
- Microsoft Office
Quick apply
South & EE Team Regulatory Affairs Lead
Shell Energy —London
- Full-time
- Engineering
- English
- Supervising experience
Regional Ethics and Compliance Officer - International
CSL Seqirus —Maidenhead
- Full-time
- Bachelor's degree
- Travel
- Business
Global Regulatory CMC Scientist (UK)
UCB —Slough
- Master's degree
- Bachelor's degree
- Leadership
Senior Manager Regulatory Affairs Lifecycle Management Medical Devices
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
PV Systems and Processes Lead x2
CSL Seqirus —Maidenhead
- Full-time
- No degree
- Leadership
- Communication skills
Exec Director, Regulatory Affairs
Gilead Sciences —Uxbridge
- Full-time
- Hybrid work
- Management
- Doctoral degree
- English
Technical Regulatory and Market Access Lead
Viasat, Inc. —London
- Full-time
- Engineering
- Master's degree
- ICU experience
Regulatory Affairs Manager
Reckitt —Slough
- Management
- Communication skills
- Employee assistance programme
- Life insurance
Senior ESG Regulatory Operations Associate
Ralph Lauren —London
- Full-time
- Hospitality
- Organisational skills
Senior Vice President - Government, Public & Regulatory Affairs
Moody's —London
- English
- Bachelor's degree
- Financial services
8d
Senior Communications and Corporate Affairs Lead
LEO Pharma A/S —Maidenhead
- Marketing
- Project management
- AI
5d
Head of/Director, International Regulatory Affairs
Hims & Hers —London
- £140,000 - £155,000 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- AI
- Annual leave

I want to receive the latest job alerts for regulatory affairs lead in harmondsworth, gtl

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affairs lead jobs near harmondsworth, gtl

Regulatory Affairs Specialist jobs in London

Senior Vice President jobs in London

Regulatory Affairs Lead jobs in London

Director Of Regulatory Affairs jobs in London

Scientist jobs in Slough

Senior Operations Associate jobs in London

Regulatory Affairs Manager jobs in Slough

Regulatory Affairs Specialist jobs in South East Region

Regulatory Affairs Specialist jobs in Slough

Regulatory Affairs Specialist jobs in Oxford

Senior Vice President jobs in Bournemouth

Senior Consultant jobs in London

Senior Vice President jobs in Nottingham Ng1

Senior Vice President jobs in Thetford

Senior Nurse jobs in London

Regulatory Affair Associate jobs in London

Send Inclusion Lead jobs in London

Regulatory Affairs Lead jobs in Newcastle Upon Tyne

Regulatory Affairs Lead jobs in Haverhill

Senior Communication Specialist jobs in Leeds

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Cepheid -
Amersham

Apply Now

Job details

Full-time
12 days ago

Benefits

Annual leave

Qualifications

Quality management
Master's degree
Bachelor's degree

Full job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible.

This position is part of Cepheid’s On-Market Sustainment Team and is a UK-based remote position. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

The Principal Regulatory Affairs Specialist (UK, IVDR) plays a critical role in ensuring the continued IVDR compliance for Cepheid’s devices post initial IVDR certification as well as leading the UK regulatory strategy, pre-market and post market.

In this role, you will have the opportunity to:

Lead the regulatory strategy, implementation and sustainment of IVDs in the UK market.
Liaise with regulatory authorities like the Medicines and Healthcare products Regulatory Agency (MHRA) and act as an administrator for related databases such UK MHRA DORS and EUDAMED.
Recommend regulatory strategy for planned product changes for UKCA and IVDR.
Prepare and maintain UKCA and IVDR Technical Documentation.
Prepare regulatory submissions and submit change notification to the notified body and MHRA
RA lead for notified body technical reviews, surveillance reviews and certificate renewals. Including leading cross functional teams for gathering review responses.
Lead interactions with notified body / MHRA as appropriate.
Monitor the UK and EU IVD regulatory landscape and drive implementation of changes to regulations, standards and guidelines.
Serve as representative in UK and EU associations, gathering regulatory intelligence and advocating to influence regulatory policy.
Collaborate with cross functional teams. Mentor and coach other associates and cross functional teams as needed.

The essential requirements of the job include:

Bachelor’s degree in Life Science or related field + 8 years’ experience in the IVD or Medical Device industry or Master’s degree in a Life Science or related field + 6 years’ experience in the IVD or Medical Device industry.
4+ years of Regulatory Affairs experience with in vitro diagnostic and/or medical devices, including hands-on experience with EU IVDR/MDR, UKCA requirements, and technical documentation management.
Strong knowledge of global regulatory requirements and demonstrated ability to interpret regulations, assess compliance impacts, and support regulatory strategies throughout the product lifecycle.
Solid understanding of Quality Management Systems (QMS), including the application of quality principles, risk management, change control, and post-market activities within a regulated environment.
Proven ability to work effectively in cross-functional teams and communicate regulatory requirements to both technical and non-technical stakeholders.
Experience interacting with notified bodies and regulatory authorities, supporting submissions, audits, technical reviews, and compliance activities.
Hands-on experience with MHRA CTDA regulation and submissions is an advantage.

Please note that because of summer vacations, there may be a delay in reviewing applications and providing updates on your candidacy. We appreciate your patience and look forward to being in touch.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Apply Now

Refine Your Search

regulatory affairs lead jobs in harmondsworth, gtl

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Northern Europe Regulatory Affairs Director

Nutrition Specialist (Global Regulatory & Corporate Affairs)

Global Value, Access & Government Affairs Lead

Patient-Centered Outcomes Research (PCOR) Lead (UK)

Head of Regulatory Affairs - AI and P2P (100% remote)

Lead, Licensing & Regulatory Affairs - Africa, Amazon Leo Global Licensing - EMEA

Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed

South & EE Team Regulatory Affairs Lead

Regional Ethics and Compliance Officer - International

Global Regulatory CMC Scientist (UK)

Senior Manager Regulatory Affairs Lifecycle Management Medical Devices

PV Systems and Processes Lead x2

Exec Director, Regulatory Affairs

Technical Regulatory and Market Access Lead

Regulatory Affairs Manager

Senior ESG Regulatory Operations Associate

Senior Vice President - Government, Public & Regulatory Affairs

Senior Communications and Corporate Affairs Lead

Head of/Director, International Regulatory Affairs

I want to receive the latest job alerts for regulatory affairs lead in harmondsworth, gtl

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected