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SalarySenior Regulatory Affairs (Medical Devices)
I am recruiting on a permanent basis in the Yorkshire region for a Senior Regulatory Affairs Associate (senior RA Associate) to work within small QA/RA function within a medical devices business. Ideally based on site but the role could be hybrid based for the right person, with three days per week spent working from our offices in Yorkshire and working from home for up to two days per week.
The successful candidate will have a degree in science or engineering with up to 3 years’ industrial experience in undertaking regulatory submissions for class 1 or 2 medical devices. Previous experience of submissions under MDR and writing technical files is essential.
You will be responsible for Quality Assurance & Regulatory Affairs Associate (QA&RA Associate)
o Responsible and manage compliance and registration of technical product files to Medical Device Regulations (MDR)
For Class I and II devices.
o Lead and manage regulatory submissions, and advice on the regulatory requirements
o When required liaise with regulated bodies
o Investigation & resolution of complaints, Process quality improvements and traceability
o Provide control and auditing of suppliers - quality & ethical, gap analysis
o Supplier management, updating safety notice and manage product recalls
o Support the development of new products, new territories etc
The ideal candidate: Senior Regulatory Affairs Associate (senior RA Associate)
o Will have a degree or equivalent qualification in a science based subject.
o It is essential that you have a minimum of 3 years experience working with Medical devices
o Specific experience in product file management within medical devices or related products ideally with Class 2 medical devices.
o Previous industrial experience of MDR, regulatory submission, quality supplier auditing, Quality systems(QMS)
o Proactive 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, Compliance, technical files, MDR, MDD
If you believe you hold the relevant background experience and looking for a new role as Senior Regulatory Affairs Associate (senior RA Associate) within this independent successful and growing business then this is the role for you.
Please note the client cannot accept applications from candidates who are not based in the UK or who require visa sponsorship.
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.
