Senior Regulatory Associate

Job Title: Regulatory Affairs Officer/ Senior Officer

Location: Near Edinburgh, Scotland, UK

Remuneration: Attractive salary and package

An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. In this role as a Regulatory Affairs Officer/ Senior Officer, you will be responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements, and managing product license registration with the appropriate regulatory authorities worldwide. 

In addition, the role will ensure that post-market surveillance and vigilance reporting obligations are met and will maintain the post-market surveillance and vigilance processes.

Main responsibilities:

·       Maintaining regulatory compliance processes including, regulatory evaluation of changes and non-conformances, post-market surveillance, vigilance and associated reporting, and regulatory and standard watch.

·       Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate.

·       Ensuring Post-market surveillance obligations are met and maintaining the post-market surveillance process.

·       Leading and coordinating the vigilance process in interface with the complaint handling process.

·       Providing support to the Department Leader of Regulatory Affairs with regard to planning and co-ordination of activities and with regard to training and supervision of other members of the Regulatory Affairs team and to ensure continuous development of junior staff to develop their capabilities.

·       Developing product labelling regulatory requirements for products and for customer-contracted products including but not limited to package labels, product labels, and instructions for use.

Requirements:

·       A relevant degree and/or relevant work experience in a regulatory affairs environment.

·       Experience in a medical device / IVD / biotech industry

·       Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, BPDR, MEDDEV 2.12, etc.)

·       Previous experience preparing and submitting BLA, 510(k), PMA, CE mark and technical files to other worldwide regulatory authorities.

·       Experienced in meeting with, making presentations to, and negotiating with regulators.

·       Ability to prepare coherent regulatory reports and filings.

For more information please reach out to  - Please note this position does not offer sponsorship.