Audit associate Work, Jobs in Long Crendon, Bkm (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 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
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International —Marlow
- £66,814 - £134,641 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Quick apply
Associate Director Private & Trusts Assurance
Grant Thornton UK LLP —Milton Keynes
- Full-time
- Mentoring
- Tax experience
- Employee discount
Assistant Manager
Apex Group —Reading
- Full-time
- Mentoring
- Organisational skills
- Annual leave
- Employee assistance programme
GR UK&I Health & Safety Security Manager
Bosch Group —Denham
- Full-time
- Travel
- Organisational skills
- Leadership
Quick apply
Compliance Administrator
Active Care Group —Thame
- £28 - £30 an hour
- Full-time
- Microsoft Word
- Microsoft Outlook
- Databases
Quick apply
Operations Manager
Brownbill Associates —Thame
- Full-time
- Continuous improvement
- Team management
- Case management
- Annual leave
- Employee assistance programme
Quick apply
Business Assurance Associate
Howden Group Holdings —Milton Keynes
- Full-time
- Hybrid work
- Microsoft Powerpoint
- English
- Organisational skills
Fulfilment Associate
PLUG JP LIMITED —Amersham Station
- £14 - £18 an hour
- Part-time
- Quality control
- Organisational skills
- Warehouse experience
- Free parking
- Employee discount
Quick apply
12d
Clinical Lead
Brownbill Associates —Thame
- Full-time
- Hybrid work
- Business development
- Supervising experience
- Case management
- Employee assistance programme
- Referral programme
Quick apply
Audit Graduate
Azets —Beaconsfield
- Full-time
- Hybrid work
- Bachelor's degree
- Employee assistance programme
- Employee discount
Quick apply
10d
Associate Quality and Systems Manager – (Asbestos, Fire & Water)
Tetra Tech —Abingdon
- Hybrid work
- Continuous improvement
- Travel
- Leadership
Local Study Associate Director
IQVIA —Reading
- Full-time
- Remote
- English
- Bachelor's degree
- No degree
- Work from home
(Fixed-Term) Manufacturing Associate I
Moderna, Inc. —Oxford
- 12 hour shift
- Bachelor's degree
- Continuous improvement
- No degree
- Annual leave
21h
(Fixed Term) Manufacturing Associate I
Moderna, Inc. —Oxford
- 12 hour shift
- Bachelor's degree
- Continuous improvement
- No degree
- Annual leave
21h
Consultant in Clinical Genetics
Oxford University Hospitals NHS Foundation Trust —Oxford
- £113,565 - £150,569 a year
- Part-time
- Patient care
- Mentoring
- Teaching
Manager, Distribution - IPSUK
Ingram Content Group —Bradwell
- 12 hour shift
- Continuous improvement
- Team management
- Quality control
- Free parking
- Sick pay
Quick apply
Automation & Platform Engineer
Capgemini —Abingdon
- Hybrid work
- Travel
- APIs
- AI
Associate Director, Facilities and Engineering
Replimune —Abingdon
- Full-time
- Microsoft Word
- Computer literacy
- Engineering
Quick apply

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audit associate jobs near long crendon, bkm

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

audit associate jobs in long crendon, bkm

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director Private & Trusts Assurance

Assistant Manager

GR UK&I Health & Safety Security Manager

Compliance Administrator

Operations Manager

Business Assurance Associate

Fulfilment Associate

Clinical Lead

Audit Graduate

Associate Quality and Systems Manager – (Asbestos, Fire & Water)

Local Study Associate Director

(Fixed-Term) Manufacturing Associate I

(Fixed Term) Manufacturing Associate I

Consultant in Clinical Genetics

Manager, Distribution - IPSUK

Automation & Platform Engineer

Associate Director, Facilities and Engineering

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