My client, a Medical Diagnostics company based in Oxford, are currently searching for an experienced Regulatory Director to join their team on a permanent basis. Within this role you will be responsible for the direction and management of regulatory activities within Europe, the UK and US.
- Regulatory Affairs (RA) responsibility for delivering and maintaining regulatory approvals and clearances for product developments and related IVD products, instruments, software, automation systems and services.
- Responsibility for developing, implementing and executing regulatory strategy for selected projects in multiple markets.
- Ensuring EU, UK, US FDA and other jurisdictional regulatory and quality management systems (QMS) requirements are met.
- Submitting appropriate regulatory filings, supplements and pre-subs (or equivalents) to ensure business demands are met in a timely fashion in the EU, UK, US and other markets as appropriate.
- Ensuring regulatory and related QMS (including 21 CFR 820 Quality System Regulations) requirements, processes and procedures, such as post-market surveillance, electronic medical device reporting (eMDR) and removals and corrections (recalls) are implemented, followed and met.
- Managing Notified Body (and Competent Authority / UK MHRA) interactions and contract management to enable transition to IVDR (and UK equivalent) in the EU/UK.
- Manage US FDA interactions in relation to new filings and pre-submissions, changes and PMA supplements, or other registration activities, including inspections, recalls and eMDRs
- Specific deliverables for the role are:
- Define regulatory strategy to ensure that eventual product approvals meet the company's commercial needs with regards to Tb and other related businesses or acquired businesses.
- Manage all interactions with key regulatory bodies (Notified Bodies, MHRA, HPRA, CDRH and others) with respect to TB products and services.
- Ensure EU CE Mark (and UK equivalent) certifications are maintained throughout transition to IVDR and that appropriate plans are in place to secure ongoing CE certification pre- and post-transition.
- Support the process during MDSAP, ISO, NMPA, US FDA or other regulatory body inspections of any OI or associated facilities / sites, including those of critical suppliers and partners.
- Work with marketing to ensure that marketing collateral and promotional pieces are compliant with our technical data and meet FDA and other relevant local regulatory requirements.
Technical skills and abilities:
- >10 years' experience in the development and approval of medical device (preferably IVD) products
- >10 years' experience in an appropriate regulatory role within med tech (IVD) businesses
- Experience of having successfully gained approval for PMA / PMA Supplements, 510(k) clearance and CE Mark certification; additional experience of international registrations would be an advantage
- Comfortable with a dynamic and changing environment, preferably with experience in IVD kits, instrumentation, software and automation.
- Experience of having launched products that changed clinical practice (i.e. not just "me too" products) a distinct advantage
- Experience of launching (gaining approval and/or clearance for) diagnostic products; ideally including both 'wet' science and automation/instrumentation a distinct advantage.
For further details, please contact Tim Barratt on 01728 716 626 or email email@example.com