Regulatory Affairs Department Leader

SRG are working with an exciting biotechnology organisation with a global presence to help them find a Department Lead within Regulatory Affairs (RA).

This is a great opportunity for someone with a wealth of experience in the field of Regulatory Affairs within IVD/IVDRs.

The company offer an excellent benefits package and a chance to lead an experienced team.

The role:

• 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
• 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 on all aspects of US FDA, European and worldwide Regulatory Legislation 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.
• 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 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.

Requirements:

• 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
• 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.
• Understanding of budgetary process and requirements for managing a department.
• Previous department management experience with strong leadership skills to manage a team. High sense of responsibility and accountability to ensure compliance and to inspire colleagues to do the same.
• Effective relationship building, negotiation and influencing skills both internally with other functional teams and externally with regulatory bodies, customers and distributors.
• Strong time management and prioritisation skills, able to work in a fast-paced work environment and respond flexibly to meet changing deadlines and priorities.
• Continued interest in updating own knowledge and skills and transferring knowledge to others.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.