Regulatory affairs specialist Work, Jobs in Enfield, Gtl (with Salaries)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
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
Quality and Regulatory Manager
Advanced Healthcare Technology Ltd —Waltham Cross
- £50,000 - £60,000 a year
- Full-time
- No degree
- Organisational skills
- In-person
- Free parking
Quick apply
Regulatory Data Specialist - Contract Role 12 months
Synthomer (UK) Limited —Harlow
- Hybrid work
- Continuous improvement
- Employee assistance programme
Quick apply
2d
Medical Information Specialist - US Hours
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- English
Quick apply
Medical Information Specialist - Afterhours
EVERSANA —London
- Weekend availability
- Remote
- Microsoft Word
- Microsoft Excel
- English
Quick apply
4d
Analyst - Regulatory Market Access and Compliance
Access Partnership —London
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Expert Consultant – Healthcare | Safety, Risk & Regulatory
Boston Consulting Group —London
- Full-time
- Doctoral degree
- Master's degree
- Business development
1d
Director - Regulatory Affairs Lifecycle Management Non-Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
South & EE Team Regulatory Affairs Lead
Shell Energy —London
- Full-time
- Engineering
- English
- Supervising experience
Director - Regulatory Affairs Lifecycle Management Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
Specialist, Quality Audits - Biosimilars
Advanz Pharma —London
- Travel
- APIs
- Employee assistance programme
5d
Medical Affairs Advisor
GlaxoSmithKline —London
- Full-time
- IT
- Leadership
4d
Account Executive - Agricultural Regulatory Intelligence
FoodChain ID Group, Inc —London
- Full-time
- Remote
- Sales
- Salesforce
- English
11d
VodafoneThree - Senior Counsel – Customer Regulatory Implementation and Delivery
VodafoneThree —London
- Full-time
- Hybrid work
- Communication skills
- Employee discount
Quick apply
South & EE Team Regulatory Affairs Lead
Shell —London
- Full-time
- Engineering
- English
- Supervising experience
Medical Information Specialist - German & English speaking
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- English
Quick apply
Senior Corporate Counsel Lead - AI Regulatory
FIS Global —London
- Full-time
- Analysis skills
- Financial services
- AI
Senior Manager – ESG and Sustainability Regulatory Legal
Pwc UK —London
- Full-time
- Hybrid work
- Analysis skills
- Presentation skills

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regulatory affairs specialist jobs near enfield, gtl

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Cepheid -
Amersham

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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

regulatory affairs specialist jobs in enfield, gtl

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Nutrition Specialist (Global Regulatory & Corporate Affairs)

Senior Regulatory Specialist

Quality and Regulatory Manager

Regulatory Data Specialist - Contract Role 12 months

Medical Information Specialist - US Hours

Medical Information Specialist - Afterhours

Analyst - Regulatory Market Access and Compliance

Expert Consultant – Healthcare | Safety, Risk & Regulatory

Director - Regulatory Affairs Lifecycle Management Non-Medicines

South & EE Team Regulatory Affairs Lead

Director - Regulatory Affairs Lifecycle Management Medicines

Specialist, Quality Audits - Biosimilars

Medical Affairs Advisor

Account Executive - Agricultural Regulatory Intelligence

VodafoneThree - Senior Counsel – Customer Regulatory Implementation and Delivery

South & EE Team Regulatory Affairs Lead

Medical Information Specialist - German & English speaking

Senior Corporate Counsel Lead - AI Regulatory

Senior Manager – ESG and Sustainability Regulatory Legal

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