Principal Work, Jobs in Amersham, Bkm (with Salaries)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
11d
Band 3 Nuclear Protective Security Inspector
Office for Nuclear Regulation —London
- £71,196 - £81,794 a year
- Hybrid work
- Analysis skills
- Presentation skills
- Bachelor's degree
- Relocation assistance
- Annual leave
Head of Learning & Development
Trainline —London
- £100,000 - £110,000 a year
- Full-time
- Hybrid work
- Leadership
Personal Assistant to an Ultra-High-Net-Worth Individual (UHNWI)
Insignia Group —London
- Weekend availability
- Hybrid work
- English
- Master's degree
- Bachelor's degree
Quick apply
11h
Principal Internal Programme Manager Data Office
NTT Global Data Centers —Hemel Hempstead
- Full-time
- Project management
- IT
- Leadership
BBC Studios Runners Pool (Genre-Wide)
BBCSTUDIOS —London
- No experience needed
- Annual leave
Family Time Supervisor
Family Action —Hemel Hempstead
- From £25,176 a year
- Part-time
- Microsoft Office
- Experience working with children
- Travel
- Free parking
- Sick pay
Quick apply
11d
Senior Democratic Services Officer (P01745)
Welwyn Hatfield Borough Council —Welwyn Garden City
- £41,992 - £45,089 a year
- English
- Communication skills
- Free parking
- Annual leave
10d
Associate Principal/Principal Qualitative Research, Patient Centered Solutions
IQVIA —Reading
- Full-time
- Hybrid work
- Management
- Doctoral degree
- Data analysis skills
Paralegal, Legal Services Manager – Operations & Asset Management
Marriott International, Inc —London
- Full-time
- Hybrid work
- Hospitality
- English
- Microsoft Office
Principal Consultant Operations EurAsia, Integrated Health Solutions
Medtronic —Watford
- £60,000 - £107,160 a year
- Full-time
- Master's degree
- Project management
- Driving
Sr Principal Sourcing NPI
PerkinElmer —High Wycombe
- Engineering
- Master's degree
- Bachelor's degree
FE/HE Partnership Manager
UK School of English —Harrow
- £15 - £25 an hour
- Hybrid work
- CRM software
- Marketing
- Salesforce
Quick apply
Director of People
Buckinghamshire Fire & Rescue Service —Aylesbury
- £123,513 a year
- Full-time
- No degree
- Human resources
- Leadership
- Annual leave
- Employee assistance programme
7d
Principal Close Protection Refresher Trainer / Instructor
Assured SIA Training Solutions —Watford
- From £190 a day
- Temporary
- English
- Education
- Plumbing
Quick apply
Associate Director, Internal Communications and Engagement
CSL Seqirus —Maidenhead
- Full-time
- Bachelor's degree
- Travel
- Leadership
Assistant Educational Psychologists
Hertfordshire County Council —Kings Langley
- £37,265 - £41,616 a year
- Doctoral degree
- English
- Bachelor's degree
11d
International Education Partnerships Manager
OXBRIDGE ACADEMY LTD —London
- £55,000 - £60,000 a year
- Full-time
- Hybrid work
- Management
- English
- Master's degree
Quick apply
6d
Principal Therapist
THE NATIONAL AUTISTIC SOCIETY —Radlett
- Up to £54,931 a year
- Full-time
- School
- Annual leave
- Employee assistance programme
Head of Business Development
WJ UK —Kings Langley
- £90,000 - £100,000 a year
- Full-time
- Management
- Sales
- Marketing
- Health & wellbeing programme
- Gym membership
Quick apply
7d

I want to receive the latest job alerts for principal in amersham, bkm

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

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Cepheid -
Amersham

Apply Now

Job details

Full-time
11 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

principal jobs in amersham, bkm

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Band 3 Nuclear Protective Security Inspector

Head of Learning & Development

Personal Assistant to an Ultra-High-Net-Worth Individual (UHNWI)

Principal Internal Programme Manager Data Office

BBC Studios Runners Pool (Genre-Wide)

Family Time Supervisor

Senior Democratic Services Officer (P01745)

Associate Principal/Principal Qualitative Research, Patient Centered Solutions

Paralegal, Legal Services Manager – Operations & Asset Management

Principal Consultant Operations EurAsia, Integrated Health Solutions

Sr Principal Sourcing NPI

FE/HE Partnership Manager

Director of People

Principal Close Protection Refresher Trainer / Instructor

Associate Director, Internal Communications and Engagement

Assistant Educational Psychologists

International Education Partnerships Manager

Principal Therapist

Head of Business Development

I want to receive the latest job alerts for principal in amersham, bkm

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected