Department Leader Regulatory Affairs - IVD's

JR United Kingdom; Luton; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading IVD manufacturer is seeking a Department Leader for Regulatory Affairs, based in Luton, UK, with responsibilities spanning regulatory compliance and team leadership. This full-time role involving remote work requires a significant background in filing US and EU regulatory applications, and offers relocation support for the right candidate.

Benefits

Relocation support

Remote work flexibility

Qualifications

• 10+ years of experience in Regulatory Affairs.
• Extensive knowledge of US and EU regulatory applications.
• Proven track record in filing regulatory submissions.

Responsibilities

• Lead the Regulatory Affairs team and manage regulatory compliance activities.
• Compile and maintain technical documentation for product registrations.
• Advise on regulatory legislation and manage submissions to regulatory bodies.

Skills

Regulatory compliance

Leadership

Document management

Analytical skills

Education

Degree in a relevant field

Job description

Department Leader Regulatory Affairs - IVD's, luton, bedfordshire

Client:

Cpl Life Sciences

Location:

luton, bedfordshire, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

Job Views:

5

Posted:

26.06.2025

Expiry Date:

10.08.2025

Job Description:

Job Title: Department Leader – Regulatory Affairs– IVDs

Job Type: Full-Time, permanent position

Location: Outskirts of Edinburgh, Scotland, UK – (1 week per month on site)

The role is a full-time, permanent position working 37.5 hours per week. Reporting to the Head of Quality and Regulatory Affairs. This role requires 1 week per month on site, the rest will be remote, based from home in the UK.

An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. As a Regulatory leader, you will be responsible for leading the team and ensuring continuous improvements within the Regulatory function.

Responsible for the initial registration of new products and for ensuring the continued registration for all products after initial registration or approval, by liaising with regulatory bodies to address compliance issues and to provide this information to the appropriate staff groups. The Department Leader for Regulatory Affairs is also responsible for acting as an active participant in team meetings that relate to changes to developed products that will require further registration and regulatory submissions.

The Department Leader is also responsible for managing and supporting the regulatory team, as well as supporting other members of regulatory affairs team across the wider group as required. The Department Leader is also responsible for supporting customer organisations with the appropriate documentation to facilitate registration/maintenance of products.

Key Responsibilities:

• Serve as a member of the Regulatory and Quality Management Team for oversight and guidance of the entire organisation on RA and Quality strategy and activities
• Ensure that technical documentation and the EU declaration of conformity of the devices for which the business is the legal manufacturer are drawn up and kept up to date
• Manage, prepare and maintain regulatory documentation to enable the Company to comply with ISO13485 standard and to ensure regulatory compliance with the 98/79/EC IVD Directive (IVDD), Regulation (EU) 2017/746 (IVDR), FDA Code of Federal Regulations and Canadian Medical Device Regulations, Part 1 as well as regulations required for rest of world submissions.
• Interpret complex legislation and provide expert advice to Management and all staff on all aspects of US FDA, European and worldwide Regulatory Legislation relevant to activities and collaborative undertakings with external organisations
• Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), ISO13485 standard, the 98/79/EC IVD Directive, Regulation (EU) 2017/746 (IVDR), FDA Regulations, Health Canada Medical Device Regulation, Part 1 (SOR/98-282)
• Contribute to the design and implementation of new quality systems and procedures and identify areas for potential improvement to ensure the concept of continuous quality improvement is realised
• Lead in the management, planning, coordination, preparation and interpretation of relevant information necessary for product licence applications to ensure successful granting, maintenance and development of such licenses by the FDA including but not limited to BLA, 510(k) and PMA submissions for immunohaematology reagents.
• Compile and submit initial registration/approval submissions in international markets post initial submission in EU, USA and other large territories
• Compile product information for the preparation of technical files and regulatory dossiers to support product license applications and product licence maintenance for worldwide Regulatory Authorities
• Review analytical data from laboratory processes, clinical field trials and product evaluation data to support product registration and licence applications
• Advise staff on data and information required for successful licence applications and registrations and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission
• Lead RA team in the assessments of product changes for impact to existing registration/approvals
• Compile and submitproduct change notifications to regulatory agenciesas required
• Support and guide team members in the preparation of technical files and regulatory dossiers to support product licence applications and product licence maintenance for the worldwide regulatory authorities
• Serve as Company contact for regulatory/registration activities with third party business partners
• Ensure continued registration by completing necessaryregistration renewals as required
• Conduct routine regulatory reporting required as condition of approval (FDA Annual Reports)
• Liaise with regulatory agencies and external customers/distributors to provide information to support regulatory processes and to confirm compliance issues
• Support budget preparation and maintenance of budget utilisation
• Lead recruitment and team management
• Perform any other duties as reasonably requestedfrom the Companyfrom time to time.
• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements.

Qualifications/Requirements:

• A relevant degree or professional qualification and extensive experience in a regulatory affairs environment.
• At least 10 years within RA.
• Extensive experience of filing US regulatory applications (BLA, 510(k), PMA submissions) and EU CE marking (IVDD/IVDR) applications.

For more information, please reach out to me at [e-mail]

This role can offer relocation support to the right candidate that matches the requirements however you MUST hold the FULL right to work in the UK. The business does not offer sponsorship.

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information.

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Created on 26/06/2025 by JR United Kingdom