Director of Regulatory Affairs

Director of Regulatory Affairs
  • £100,000 - £120,000 per Annum
  • Permanent
  • Oxfordshire, England, UK Oxfordshire UK OX14 4RY
Job Ref: J36097
Sector: Science
Sub-sector: Biotech/Life Sciences
Date Added: 15 July 2020
My client is a world leader within the Biotechnology space and headquartered in Oxfordshire. They are recruiting a business critical role titled Direc

My client is a world leader within the Biotechnology space and headquartered in Oxfordshire. They are recruiting a business critical role titled Director of Regulatory Affairs. The role itself will be responsible for the management and strategic direction of all regulatory affairs in all markets including EU, UK & US. - This role will be responsible for delivering and maintaining regulatory approvals and clearances for product development and related R&D projects including instruments, software and automation. - The remit for this role will be extensive covering UK, US, EU and the post holder will ensure FDA and other regulatory frameworks are adhered to. - The post holder will be 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.- You will be ensuring regulatory and related QMS (including 21 CFR 820 Quality System Regulations) requirements, processes and procedures.- Manage US FDA interactions in relation to new filings and pre-submissions, changes and PMA supplements, or other registration activities, including inspections, recalls and eMDR- Manage all interactions with key regulatory bodies (Notified Bodies, MHRA, HPRA, CDRH and others) with respect- 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-transitionQualifications* Extensive experience in the development and approval of medical device (preferably IVD) products* Extensive experience in an appropriate regulatory role within med tech (IVD) businesses* First-hand experience of managing regulatory processes* 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* Strong background in successful management of complex, major projects of strategic importance* Experience in manufacturing and quality functions an advantage* 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.If you or anybody in your network is interested then please get in touch on 0121 726 9711 or

14/08/2020 13:13:49
GBP 100000.00 100000.00
Contact Consultant:
Marcus Jolly

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