Quality Assurance & Regulatory Affairs Associate

I am recruiting on a permanent basis in the Yorkshire region for a Quality Assurance & Regulatory Affairs Associate (QA&RA Associate) to work within small QA/RA function within a medical devices business. The role could be hybrid based, with three days per week spent working from our offices and working from home for up to two days per week.

The successful candidate will have a degree in science or engineering with at least 5 years' experience in undertaking regulatory submissions for class 1 or 2 medical devices. Previous experience of submissions under MDR and for distributed territories is essential.

Key Responsibilities for Quality Assurance & Regulatory Affairs Associate (QA&RA Associate)

Generation of Technical Files and Device Master Records for new devices / newly registered devices within the given territory. Lead and manage regulatory submissions, and advice on the regulatory requirements for such.

You will be responsible for Quality Assurance & Regulatory Affairs Associate (QA&RA Associate)

o Responsible for compliance, diligence and registration of technical product files to Medical Device Regulations (MDR)

For Class I and II devices.

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 Manage CAPA tracking, NCR updating and ensure all documentation is up to date

o Supplier management, updating safety notice and manage product recalls

The ideal candidate: Quality Assurance & Regulatory Affairs Associate (QA&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 5 years experience on 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 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 Quality Assurance & Regulatory Affairs Associate (QA&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.