Regulatory Compliance Associate 

I am recruiting on a permanent basis in the Yorkshire region for a Regulatory Compliance Associate to work within a healthcare  business. Responding to market opportunity and business requirements within online and regulated sectors.

You will be responsible for:

• • Responsible for delivery of projects within regulatory compliance – Biocides and Medical devices
  • Learn and develop knowledge of regulatory submissions including PT1 and PT2 products under BPR transitional rules
  • Attention to detail for the compliance and diligence of product technical product files
  • As required provide and support advice in Medical Device Regulations (MDR) – Biocides (BPR)
  • When required liaise with regulated bodies
  • Compile and control product technical files for all product family registrations
  • Review compliance and update existing product technical files.
  • Experience in Post Market Surveillance PMS, collation, review and writing

The ideal candidate:

• • Will have a degree or equivalent qualification in a science based subject.
  • Ideally that you have a minimum of 2 years experience on product file management within medical devices or related products ideally with medical devices MDD and MDR (13485) or Biocides (528/2012)
  • Ideally previous industrial experience of MDR, regulatory submission, quality supplier auditing, Quality systems(QMS)
  • Keen to learn and develop to become a technical specialist within regulatory projects
  • Positive communication engaging with all levels and proactive

Key Words: QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, regulatory affairs, ISO13485, BPR, HACCP, Compliance, technical files, MDR,

If you believe you hold the relevant background experience and looking for a new role as Regulatory Compliance Lead 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.