Regulatory Officer - Diagnostics

An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department.

Responsible for managing product licence registration with the appropriate regulatory authorities on a worldwide basis. This includes the preparation of any regulatory dossiers and/or supporting documentation. In addition, the department will manage the maintenance of such registrations/licenses once granted.:

Main responsibilities:

· 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.

· Prepare and compile regulatory documentation, coordinate and execute regulatory submission for countries including US, EU, Canada and any other territories as appropriate in compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate.

· Advise staff and project team members on data and information required for successful license applications and coordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.

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

· Liaise with internal and external parties as required to support the development of product labelling.

· Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents and industry standards.

· Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, 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).

· 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.

· 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 lucy.kirkaldy@cpl.com