Department Leader, Regulatory Affairs

AliveDx; Penicuik; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading diagnostics company based in Penicuik is looking for a Department Leader for Regulatory Affairs. This full-time role involves overseeing regulatory compliance, managing documentation for US and EU applications, and leading a team to ensure standards are met. Ideal candidates will have extensive experience in regulatory affairs and leadership. Competitive salary and a range of benefits are on offer.

Benefits

Private medical cover

Life assurance

Cycle to work

Technology discounts

Restaurant discounts

Qualifications

• Extensive experience in a regulatory affairs environment.
• Experience in US regulatory applications and EU CE marking.
• Previous department management experience.

Responsibilities

• Oversee and guide the organisation on regulatory and quality strategy.
• Manage regulatory documentation for compliance.
• Lead license application preparation for FDA submissions.

Skills

Regulatory application filing (BLA, 510(k), PMA)

Data analysis and interpretation

Knowledge of ISO13485 and IVDD/IVDR compliance

Leadership skills

Education

Relevant degree or professional qualification

Job description

Overview

Building on 30 years of experience in transfusion diagnostics, AliveDx is committed to delivering solutions that reshape the way diagnostics is practiced. AliveDx has two key product portfolios, Alba by Quotient™ and MosaiQ™ by Quotient. The Alba by Quotient™ product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. AliveDx operations are based in Eysins, Switzerland, Edinburgh, Scotland and Chicago, Illinois.

Department leader, REGULATORY AFFAIRS

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-Friday.

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 license 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 license maintenance for worldwide Regulatory Authorities.
• Review analytical data from laboratory processes, clinical field trials and product evaluation data to support product registration and license applications.
• Advise Alba staff on data and information required for successful license applications and registrations and co-ordinate 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 offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.