Regulatory specialist Work, Jobs in Welwyn, Hrt (with Salaries)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
10d
Sr. Specialist, Regulatory Affairs
The Bountiful Company —Tring
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Regulatory Specialist
Sensient Technologies Corporation —Milton Keynes
- English
- Microsoft Office
- Bachelor's degree
9d
Training & Education Specialist, Urology - EMEA (Sacral Neuromodulation)
Boston Scientific —Welwyn
- Hybrid work
- English
- Analysis skills
- Project management
Nutrition Specialist (Global Regulatory & Corporate Affairs)
Oatly AB —London
- Part-time
- Hybrid work
- English
- Master's degree
- Travel
Quick apply
Senior Regulatory Specialist
Androlabs —London
- £85,000 - £108,000 a year
- Full-time
- Hybrid work
- IT
- Annual leave
Quick apply
11d
Senior Operations Specialist (Regulatory Transaction Reporting)- London
FDM Group —London
- Hybrid work
- Data analysis skills
- SQL
- Annual leave
Regulatory Change Implementation Specialist - 2026
Suade —London
- £50,000 - £75,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- English
- Bachelor's degree
- Annual leave
- Work from home
Quick apply
Global Mobility Advisor
Leonardo UK Ltd —Luton
- £50,000 - £55,000 a year
- Full-time
- Hybrid work
- Data analysis skills
- Flexible schedule
- Referral programme
Product Specialist - South East
Accora —St Albans
- Full-time
- Remote
- English
- Organisational skills
- IT
- Annual leave
Quick apply
Legal Contract Administrator (m/f/d)
NTT Global Data Centers —Hemel Hempstead
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
13d
Medical Information Specialist - US Hours
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- English
Quick apply
Specialist, Sourcing - DC Operations
NTT Global Data Centers —Hemel Hempstead
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- Business
APQP Specialist - 12m Inside IR35 Contractor
Safran Engineering Services UK Limited —Pitstone
- Engineering
- Analysis skills
- Bachelor's degree
Quick apply
Sourcing/Procurement Specialist (Hybrid)
Thermo Fisher Scientific —Hemel Hempstead
- Full-time
- Hybrid work
- English
- Analysis skills
- Bachelor's degree
Regulatory Reporting Implementation Specialist - 2026
Suade —London
- £45,000 - £60,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- English
- Bachelor's degree
- Annual leave
- Work from home
Quick apply
Continuous Improvement & Innovation Specialist
PerkinElmer —Seer Green
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Fund Accounting Senior Specialist
Janus Henderson —London
- Hybrid work
- Microsoft Excel
- Accounting
- Communication skills
Regulatory Compensation Specialist
Bank of America —London
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Employee assistance programme
Chartered Surveyor - Health Complex Caseworker
HM Revenue and Customs —Croydon
- £59,342 a year
- Part-time
- Hybrid work
- Presentation skills
- Travel
- Negotiation
- Work from home
5d

I want to receive the latest job alerts for regulatory specialist in welwyn, hrt

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 specialist jobs near welwyn, hrt

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Cepheid -
Amersham

Apply Now

Job details

Full-time
10 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 specialist jobs in welwyn, hrt

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Sr. Specialist, Regulatory Affairs

Regulatory Specialist

Training & Education Specialist, Urology - EMEA (Sacral Neuromodulation)

Nutrition Specialist (Global Regulatory & Corporate Affairs)

Senior Regulatory Specialist

Senior Operations Specialist (Regulatory Transaction Reporting)- London

Regulatory Change Implementation Specialist - 2026

Global Mobility Advisor

Product Specialist - South East

Legal Contract Administrator (m/f/d)

Medical Information Specialist - US Hours

Specialist, Sourcing - DC Operations

APQP Specialist - 12m Inside IR35 Contractor

Sourcing/Procurement Specialist (Hybrid)

Regulatory Reporting Implementation Specialist - 2026

Continuous Improvement & Innovation Specialist

Fund Accounting Senior Specialist

Regulatory Compensation Specialist

Chartered Surveyor - Health Complex Caseworker

I want to receive the latest job alerts for regulatory specialist in welwyn, hrt

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected