Science medical affairs Work, Jobs in London, Eng (with Salaries)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
Medical Information Specialist - German & English speaking
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- English
Quick apply
Medical Science Liaison
Merz Aesthetics GmbH —Hemel Hempstead
- Nursing
- Microsoft Office
- Driving
Quick apply
Account Executive, Health
MHP Group —London
- Hybrid work
- Project management
- Communication skills
- Time management
- Employee assistance programme
- Employee discount
1d
Research in Practice - PhD placement
Chatham House —London
- Full-time
- Hybrid work
- Doctoral degree
- Research
- Leadership
8d
Vice President, International Medical Affairs
Viridian Therapeutics, Inc. —London
- £270,000 - £310,000 a year
- Full-time
- Management
- Doctoral degree
- Travel
Quick apply
Medical Science Liaison (Northern Europe)
Establishment Labs —London
- Full-time
- Doctoral degree
- Travel
- Communication skills
Quick apply
Associate Director, Medical Affairs
Gilead Sciences —Uxbridge
- Full-time
- Doctoral degree
- Analysis skills
- Project management
14d
Manager Global Scientific Affairs
Sobi —London
- Full-time
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Doctoral degree
Quick apply
8d
Director, Medical Affairs & Policy | UK
Harrison.ai —London
- Full-time
- Doctoral degree
- AI
- Work from home
- Flexible schedule
14d
Research Scientist, Health Economic Modelling
Precision Medicine Group —London
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Doctoral degree
8d
Associate Director, Global Medical Affairs (2-year contract)
BioNTech AG —London
- Full-time
- Doctoral degree
- Project management
- Travel
Global Medical Affairs Research Grant & Study Manager
Santen —St Albans
- £78,863 - £108,436 a year
- Full-time
- Remote
- Nursing
- Doctoral degree
- English
Quick apply
7d
Scientific Affairs Manager, UK - London
Rhythm Pharmaceuticals —London
- Full-time
- Doctoral degree
- Presentation skills
- Communication skills
Senior Medical Science Liaison (solid tumours)
BioNTech AG —London
- Full-time
- Doctoral degree
- Master's degree
- Project management
7d
Laboratory Scientist (ID4792, ID4618, ID4811)
Animal and Plant Health Agency —New Haw
- £33,350 a year
- Overtime
- Doctoral degree
- Computer literacy
- Laboratory experience
- Annual leave
- Employee discount
1d
Managing Director, Medical Affairs Consulting
サイネオス・ヘルス —London
- Sales
- Master's degree
- Business development
Clinical Data & Device Specialist
SAVA —London
- Maths
Quick apply
Managing Director, Medical Affairs Consulting
Syneos Health Commercial Solutions —London
- Master's degree
- Business
Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology
Recordati —Hemel Hempstead
- Full-time
- Hybrid work
- English
- Quality control
- Travel
10d

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Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Cepheid -
Amersham

Apply Now

Job details

Full-time

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

science medical affairs jobs in london, eng

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Medical Information Specialist - German & English speaking

Medical Science Liaison

Account Executive, Health

Research in Practice - PhD placement

Vice President, International Medical Affairs

Medical Science Liaison (Northern Europe)

Associate Director, Medical Affairs

Manager Global Scientific Affairs

Director, Medical Affairs & Policy | UK

Research Scientist, Health Economic Modelling

Associate Director, Global Medical Affairs (2-year contract)

Global Medical Affairs Research Grant & Study Manager

Scientific Affairs Manager, UK - London

Senior Medical Science Liaison (solid tumours)

Laboratory Scientist (ID4792, ID4618, ID4811)

Managing Director, Medical Affairs Consulting

Clinical Data & Device Specialist

Managing Director, Medical Affairs Consulting

Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology

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