Senior Regulatory Affairs Associate

Job Description

Senior Regulatory Affairs AssociateI 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. The role could be hybrid based, with three days per week spentworking 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’ 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 Senior Regulatory Affairs Associate (senior 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 and manage compliance and registration of technical product files to Medical Device Regulations (MDR)For Class I and II devices.o When required liaise with regulated bodieso Investigation & resolution of complaints, Process quality improvements and traceabilityo Provide control and auditing of suppliers - quality & ethical, gap analysiso Manage CAPA tracking, NCR updating and ensure all documentation is up to dateo Supplier management, updating safety notice and manage product recallso Support the development of new products, new territories etcThe 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 deviceso 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 Proative and engaging with the continued growth of the brand and businesso Positive communication engaging with all levels and proactiveKey Words: QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, regulatory affairs, ISO13485, Compliance, technical files, MDR, MDDIf 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 thatthey are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency.

Keyskills :
Medical DevicesRegulatory AffairsRegulatory SubmissionsTechnical FilesFile Management