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Regulatory Affairs specialist
My client, a leading regulatory consultancy based in Yorkshire are expanding and looking to recruit a medical devices Regulatory Affairs professional on permanent basis. The role will be based on site.
You will be responsible for
o Responsible for compliance and diligence of product technical product files
o Provide and support advice and technical updates in Medical Device Regulations (MDR) Class 2 & 3.
o Liaise with regulated bodies submissions, queries and clarity.
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
o Provide input and support to site leadership and business direction
To be considered for a role in Regulatory Affairs, you should possess the following:
Proven experience in the regulated environment Medical devices industry in QA, Quality Assurance and RA Regulatory Affairs.
Previous industrial experience of MDR, regulatory submission, project management, quality supplier auditing, Quality systems(QMS)
Knowledge/experience of relevant legislation MDR
A degree in life science, STEM or related subject
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 Specialist within this independent successful and growing business then this is the role for you.
About us: Templarfox is 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.
