Regulatory Affairs Associate Medical Devices
Posted 3 days 9 hours ago by TemplarFox Consultancy
Regulatory Affairs Associate Medical Devices - Yorkshire - £competitive
I am recruiting on a permanent basis in the Yorkshire region for a Regulatory Affairs (RA) Associate to work within a medical devices business. The client is agile and looking to develop new products supporting patient health and well being. Responding to market opportunity and business requirements within retail and regulated sectors.
You will be responsible for
o Responsible for compliance and diligence of product technical product files
o Provide and support advice in Medical Device Regulations (MDR) - Class I and IIa.
o When required liaise with regulated bodies
o Compile and control product technical files for all new MDR product registrations
o Review compliance and update existing product technical files.
o Experience in Post Market Surveillance PMS, collation, review and writing
The ideal candidate:
o Will have a degree or equivalent qualification in a science based subject.
o It is essential that you have a minimum of 2 years experience on product file management within medical devices or related products ideally with Class 1 or Class 2 medical devices.
o Previous industrial experience of MDR, regulatory submission, quality supplier auditing, Quality systems(QMS)
o Proative and engaging with the continued growth of the brand and business
o Positive communication engaging with all levels and proactive
Key Words: QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, regulatory affairs, ISO13485, BRC, HACCP, Compliance, technical files, MDR,
If you believe you hold the relevant background experience and looking for a new role as RA Associate within this independent successful and growing business then this is the role for you.
About us: Templarfox if a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency.