Regulatory Affairs Consultant

4 weeks ago

London, United Kingdom Brightwork Ltd Full time

BaxMed – Ad-Hoc Senior Regulatory Affairs Consultant
Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment to simplifying the complexities of Regulatory Affairs, BaxMed offers a comprehensive range of services tailored to guide organisations to success in the highly regulated medical device and in vitro diagnostic space.
Role – Ad-Hoc Senior Regulatory Affairs Consultant
Brightwork is delighted to be supporting BaxMed as they seek to recruit an Ad-Hoc Senior Regulatory Affairs Consultant. Supporting a highly varied client base, start-up / early stage to well established, you will have a varied and interesting role providing support on an ad-hoc / as required basis, your role including;
Working on dedicated client projects as a Regulatory Affairs Consultant
Provision of comprehensive regulatory affairs support to a highly varied client base, predominantly within the Medical Device and related sectors
Provide leadership and expertise in regulatory and submissions-related aspects for all elements of product development from initial concept through all design stages, through clinical trials to scale-up
Providing technical support and guidance to clients in relation to Regulatory Affairs requirements, provisions and submissions
Supporting delivery of submission-specific regulatory milestones
Ideally min degree qualified within a relevant discipline, you will be a highly experienced Regulatory Affairs Consultant / Specialist. You will be able to demonstrate a proven background in providing Regulatory Affairs support, guidance and management within a highly diverse client base – direct experience within the Medical Device and associated sectors is essential. This post will be offered on a remote on-going ad-hoc basis supporting BaxMed's clients – travel to client sites may be required to meet business demands.
BaxMed Regulatory Ltd is poised to become a trusted name in the medical device sector, offering a full suite of services that span quality management systems, regulatory strategy development, in vitro diagnostic regulatory affairs, companion diagnostics regulatory affairs, medical device regulatory affairs and clinical affairs.

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