Regulatory affairs lead Work, Jobs in Reading, Brk (with Salaries)

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Databases
- Bachelor's degree
- Annual leave
Medical Affairs Coordinator
Servier —Slough
- Microsoft Office
- Databases
- Administrative experience
Patient-Centered Outcomes Research (PCOR) Lead (UK)
UCB —Slough
- Doctoral degree
- Master's degree
- Leadership
Sr Director, Drug Development Lead
IQVIA —Reading
- Full-time
- Remote
- Management
- Doctoral degree
- Master's degree
- Work from home
5d
Local Study Associate Director
IQVIA —Reading
- Full-time
- Remote
- English
- Bachelor's degree
- No degree
- Work from home
Senior Benefits Risk Management Lead
Bayer —Reading
- £110,000 - £130,000 a year
- Full-time
- Hybrid work
- English
- Databases
- Continuous improvement
- Annual leave
- Employee discount
Northern Europe Regulatory Affairs Director
Kenvue —Reading
- Hybrid work
- Management
- English
- Analysis skills
Regulatory Compliance Supervisor (m/f/x)
3M —Bracknell
- Full-time
- Engineering
- Research
- Master's degree
- Flexible schedule
Director, Medical Affairs EMEA
Kenvue —Reading
- Hybrid work
- Management
- Continuous improvement
- Travel
- Annual leave
PV Systems and Processes Lead x2
CSL Seqirus —Maidenhead
- Full-time
- Continuous improvement
- No degree
- Leadership
Director, Medical Affairs (Europe & International)
Immunocore —Oxford
- Management
- Doctoral degree
- Travel
Regulatory Quality Assurance Manager
Alliance Medical Ltd —Guildford
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Continuous improvement
Quick apply
Public Affairs & Communications Director
AALTO —Farnborough
- Leadership
- Employee assistance programme
- Employee discount
Quick apply
Head of Spectrum & Regulatory Affairs
Open Cosmos —Didcot
- Hybrid work
- Negotiation
Manager, Oncology Regulatory Strategy
Pfizer —Walton-on-Thames
- Full-time
- Hybrid work
- Communication skills
- Negotiation
7d
Client Partner, Strategy Consulting Large Pharma Advisory, 1 year contract
IQVIA —Reading
- Full-time
- Hybrid work
- Organisational skills
- Communication skills
- Negotiation
4d
Director of Public Affairs, UK
Abbott Laboratories —Maidenhead
- Full-time
- Bachelor's degree
- Budgeting
- Communication skills
Strategy & New Product Planning Associate
Biogen —Maidenhead
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Master's degree
- Analysis skills
2d
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International plc —Marlow
- £80,000 - £140,000 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Global Manager, Performance Validation - Personal Care
Elementis —Ascot
- Full-time
- Hybrid work
- English
- Bachelor's degree
- Quality control
12d

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regulatory affairs lead jobs near reading, brk

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

regulatory affairs lead jobs in reading, brk

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Medical Affairs Coordinator

Patient-Centered Outcomes Research (PCOR) Lead (UK)

Sr Director, Drug Development Lead

Local Study Associate Director

Senior Benefits Risk Management Lead

Northern Europe Regulatory Affairs Director

Regulatory Compliance Supervisor (m/f/x)

Director, Medical Affairs EMEA

PV Systems and Processes Lead x2

Director, Medical Affairs (Europe & International)

Regulatory Quality Assurance Manager

Public Affairs & Communications Director

Head of Spectrum & Regulatory Affairs

Manager, Oncology Regulatory Strategy

Client Partner, Strategy Consulting Large Pharma Advisory, 1 year contract

Director of Public Affairs, UK

Strategy & New Product Planning Associate

Associate Director Global CMC QU – Clinical GMP/GDP

Global Manager, Performance Validation - Personal Care

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