Regulatory Compliance Associate
2 weeks ago
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
- 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
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