Department Leader – Regulatory Affairs– IVD’s in Dunfermline

Job Type: Full-Time, permanent position

Location: Outskirts of Edinburgh, Scotland, UK – 3x a week on site.

Remuneration: £80,000 – £90,000 + benefits

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 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. 3x per week on site is the preference for this role; however, for the right person who ticks all the boxes, they could consider someone who can commit to 1 week per month on site.

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.

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, co-ordination, 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 licence 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 submit product change notifications to regulatory agencies as 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 necessary registration 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 requested by the Company from 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.
• Prior experience working in the technical RA/QA field with prior MedTech experience.
• Extensive experience of filing US regulatory applications (BLA, 510(k), PMA submissions) and EU CE marking (IVDD/IVDR) applications.
• Leadership experience is essential.
• Extensive post-market experience ensuring ongoing regulatory compliance.