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