Program associate Work, Jobs in Reading (with Salaries)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Databases
- Bachelor's degree
- Annual leave
Associate Director, Medical Affairs
Gilead Sciences —Uxbridge
- Full-time
- Doctoral degree
- Analysis skills
- Project management
Senior / Principal Consultant, Air Quality - Basingstoke
WSP —Basingstoke
- Part-time
- Hybrid work
- Business development
- Communication skills
- Flexitime
- Work from home
Associate Director, Business Risk Lead (EU)
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- In-person
Product Manager, Surgical Solutions - UK
BD —Winnersh
- £43,300 - £66,025 a year
- English
- Bachelor's degree
- Product management
19h
Manufacturing Operational Readiness & Start-Up Lead
Mars —Slough
- £44,000 - £55,000 a year
- Full-time
- Continuous improvement
- In-person
- Training & development
14d
Associate Director, Precision Medicine (Clinical Diagnostics)
Regeneron —Uxbridge
- Doctoral degree
- Annual leave
5d
Sales Associate - Oxford
LEGO Company Limited —Oxford
- Annual leave
- Employee discount
1d
Sales Learning Consultant
ADP —Staines-upon-Thames
- Hybrid work
- Sales
- English
- Education
Associate Director, People Operations (Europe)
Ergomed —Guildford
- Full-time
- Hybrid work
- English
- Human resources
- Training & development
Quick apply
Manager, Environmental Tox
Reckitt —Slough
- Management
- Bachelor's degree
- Continuous improvement
- Employee assistance programme
- Life insurance
Part-Time Sales Associate, Tommy Hilfiger - Oxford
Tommy Hilfiger —Oxford
- Part-time
- Communication skills
Sales Specialist, Peripheral Vascular Disease - South West & South Wales
BD —Winnersh
- £43,300 - £66,025 a year
- Presentation skills
- Travel
- Organisational skills
2d
Cost Management Associate Director/ Project Director (Health and Life Sciences)
WSP —Didcot
- Part-time
- Hybrid work
- Business development
- Contracts
- Leadership
- Flexitime
- Work from home
1d
Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based
Moderna, Inc. —Oxford
- Weekend availability
- Doctoral degree
- Master's degree
- Continuous improvement
- Annual leave
Associate Director Inspection Management (GCP)
Regeneron —Uxbridge
- Supervising experience
- Presentation skills
- Bachelor's degree
- Annual leave
Enterprise Project Manager
Sovos Compliance —Farnborough
- Spanish
- PMP
- English
Quick apply
7d
Associate Director/Director Business Development
Genomics —Oxford
- Full-time
- Hybrid work
- Business development
- Business
- Annual leave
Territory Manager, Vascular Access Management (VAM) - South West
BD —Winnersh
- £43,300 - £66,025 a year
- Organisational skills
(Fixed-Term) Manufacturing Associate, Drug Substance - Shift Position
Moderna, Inc. —Oxford
- 12 hour shift
- Bachelor's degree
- Continuous improvement
- No degree
- Annual leave

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Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Cepheid -
Amersham

Apply Now

Job details

Full-time

Benefits

Annual leave

Qualifications

Stakeholder liaison
Coaching
Quality management
Master's degree
Databases
Compliance management
Bachelor's degree
Risk management
Mentoring
Technical writing
Multidisciplinary collaboration
Document management
Cross-functional collaboration
Cross-functional communication
Corporate regulatory compliance oversight

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

program associate jobs in reading

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Associate Director, Medical Affairs

Senior / Principal Consultant, Air Quality - Basingstoke

Associate Director, Business Risk Lead (EU)

Product Manager, Surgical Solutions - UK

Manufacturing Operational Readiness & Start-Up Lead

Associate Director, Precision Medicine (Clinical Diagnostics)

Sales Associate - Oxford

Sales Learning Consultant

Associate Director, People Operations (Europe)

Manager, Environmental Tox

Part-Time Sales Associate, Tommy Hilfiger - Oxford

Sales Specialist, Peripheral Vascular Disease - South West & South Wales

Cost Management Associate Director/ Project Director (Health and Life Sciences)

Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based

Associate Director Inspection Management (GCP)

Enterprise Project Manager

Associate Director/Director Business Development

Territory Manager, Vascular Access Management (VAM) - South West

(Fixed-Term) Manufacturing Associate, Drug Substance - Shift Position

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