Regulatory Compliance Associate - Keighley, United Kingdom - TemplarFox Consultancy
Description
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:
o Responsible for delivery of projects within regulatory compliance - Biocides and Medical devices
o Learn and develop knowledge of regulatory submissions including PT1 and PT2 products under BPR transitional rules
o Attention to detail for the compliance and diligence of product technical product files
o As required provide and support advice in Medical Device Regulations (MDR) - Biocides (BPR)
o When required liaise with regulated bodies
o Compile and control product technical files for all product family registrations
o Review compliance and update existing product technical files.
o Experience in Post Market Surveillance PMS, collation, review and writing
The ideal candidate:
o Will have a degree or equivalent qualification in a science based subject.
o 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 or Biocides (528/2012)
o Ideally previous industrial experience of MDR, regulatory submission, quality supplier auditing, Quality systems(QMS)