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Regulatory Affairs Officer

4 months ago

London, United Kingdom Cpl Life Sciences Full time
Job Title:

Regulatory Affairs OfficernJob Type:

Full-time, permanent positionnLocation:

Outskirts of Edinburgh, Scotland, UK - 3x a week on sitenRemuneration:

£35,000 to £37,000 + benefits

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, 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.

Main responsibilities:nPreparing 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.nAdvise 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.nDevelop product labelling regulatory requirements for products and for customer-contracted products including but not limited to package labels, product labels and instructions for use.nLiaise with internal and external parties as required to support the development of product labelling.nContribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents and industry standards.nEnsure 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).nProviding 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.

Requirements:nA relevant degree and/or relevant work experience in a regulatory affairs environment.nExperience in a medical device / IVD / biotech industrynSpecialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, BPDR, MEDDEV 2.12, etc.)nPrevious experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to other worldwide regulatory authorities.nExperienced in meeting with, making presentations to, and negotiating with regulators.nAbility to prepare coherent regulatory reports and filings.

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