Regulatory affairs specialist Work, Jobs in Wooburn, Bkm (with Salaries)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
13d
Sr. Specialist, Regulatory Affairs
The Bountiful Company —Tring
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
Senior Manager – ESG and Sustainability Regulatory Legal
Pwc UK —London
- Full-time
- Hybrid work
- Analysis skills
- Presentation skills
Director - Regulatory Affairs Lifecycle Management Non-Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
Analyst - Regulatory Market Access and Compliance
Access Partnership —London
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Director - Regulatory Affairs Lifecycle Management Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
Junior Export Control Officer
Bosch Group —Denham
- Full-time
- Hybrid work
- No experience needed
- Microsoft Office
- Analysis skills
Quick apply
Solicitor Court of Protection
HAB Law —Watford
- £30,000 - £60,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Office
- Free parking
- Work from home
Quick apply
1d
Business Development Manager, Life Sciences
Carnall Farrar —London
- Full-time
- Hybrid work
- Bachelor's degree
- Leadership
- Health & wellbeing programme
- Employee assistance programme
Quick apply
Vice President / Associate Director, Crisis & Risk
Edelman —London
- Full-time
- Project management
- IT
Senior Counsel - Regulatory Law
Visa Europe Limited —London
- Doctoral degree
- English
- Financial services
Care Home Manager at Wellesley Road
Shaw Healthcare —Camden
- £70,000 - £75,000 a year
- Full-time
- Leadership
- Annual leave
- Referral programme
Quick apply
Country Medical Director, UK and Ireland
Gilead Sciences —London
- Full-time
- Hybrid work
- Leadership
5d
Global Brand Manager - Menopause & Contraception
Theramex —London
- Project management
- Organisational skills
- Marketing
Global Logistics Manager
The Gowan Co. —Harpenden
- Full-time
- Management
- Microsoft Office
- Master's degree
Quick apply
Senior Legal Counsel
NBCUniversal —London
- Full-time
- Contracts
- Communication skills
Legal Counsel
NBCUniversal —London
- Full-time
- Hybrid work
- Communication skills
- Negotiation
5d

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Sr. Specialist, Regulatory Affairs
The Bountiful Company —Tring
Support review of product ideations, raw material assessment, formulation assessment, new claims, labels, advertising materials, third party products and…
Quick apply
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
Liaise with regulatory authorities like the Medicines and Healthcare products Regulatory Agency (MHRA) and act as an administrator for related databases such UK…
13d

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Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Cepheid -
Amersham

Apply Now

Job details

Full-time
13 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 specialist jobs in wooburn, bkm

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Sr. Specialist, Regulatory Affairs

Senior Regulatory Affairs Specialist

Senior Manager – ESG and Sustainability Regulatory Legal

Director - Regulatory Affairs Lifecycle Management Non-Medicines

Analyst - Regulatory Market Access and Compliance

Director - Regulatory Affairs Lifecycle Management Medicines

Junior Export Control Officer

Solicitor Court of Protection

Business Development Manager, Life Sciences

Vice President / Associate Director, Crisis & Risk

Senior Counsel - Regulatory Law

Care Home Manager at Wellesley Road

Country Medical Director, UK and Ireland

Global Brand Manager - Menopause & Contraception

Global Logistics Manager

Senior Legal Counsel

Legal Counsel

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