Department Leader, Regulatory Affairs in Penicuik

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba – our blood bank reagents portfolio – and MosaiQ® – one of the first multiplexing and multimodality automated testing platforms – are designed to make labs more efficient and clinical decision-making more effective.

We are recruiting for a Department Leader to join our Regulatory Affairs Team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week, Monday to Friday.

The Department Leader for Regulatory Affairs is responsible for the initial registration of new products and for ensuring the continued registration for all Alba 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.

Main 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 Alba Bioscience Ltd 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 Alba Management and all staff on all aspects of US FDA, European and worldwide Regulatory Legislation relevant to Alba 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).
• 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 licences 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 Alba staff on data and information required for successful licence applications and registrations and coordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.

Qualifications, Experience & Behaviours Required:

• A relevant degree or professional qualification and extensive experience in a regulatory affairs environment.
• Extensive experience of filing US regulatory applications (BLA, 510(k), PMA submissions) and EU CE marking (IVDD/IVDR) applications.
• Extensive post-market experience ensuring ongoing regulatory compliance, data analysis and interpretation skills.
• Significant specialist knowledge of regulatory affairs as applied to in-vitro diagnostic medical devices and an understanding of the operation of a medical device manufacturing establishment.
• Previous department management experience with strong leadership skills to manage a team.
• High sense of responsibility and accountability to ensure compliance and to inspire.

Additional Information:

Competitive salary on offer. AliveDx offers a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.