Regulatory Affairs Director

Employer
Key People Limited
Location
Oxfordshire, England
Salary
£90000 - £105000 per annum + benefits
Closing date
23 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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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.

Responsibilities:

  • 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 tbarratt@keypeople.co.uk

International recruitment solutions

Key People is a truly international operation with offices in the UK, Switzerland and Iraq

We have developed working relationships with many of the FTSE 100 companies, including some of the world's most recognised global brands in the pharmaceutical, Oil, Gas, Energy and engineering industries.

Our dedication to both employers and candidates, and our vast experience enables us to provide superior solutions and effective results. We're proud to be a private company driven by our commitment to our customers and we are constantly exploring new markets in our bid to become the number one recruitment agency for customer satisfaction across a number of industry sectors.

Contact Us
  • Catherine House
  • Adelaide Street
  • St Albans
  • AL3 5BA
  • GB
  • +44 (0) 1727 811634
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