This position is responsible for the direction and management of regulatory activities within Oxford Immunotec Ltd. and Oxford Immunotec USA Inc. in all markets, with emphasis in EU, UK and US.
1. Regulatory Affairs (RA) responsibility for delivering and maintaining regulatory approvals and clearances for T-SPOT.TB product developments and related IVD products, instruments, software, automation systems and services.
2. Responsibility for developing, implementing and executing regulatory strategy for selected projects in multiple markets.
3. Ensuring EU, UK, US FDA and other jurisdictional regulatory and quality management systems (QMS) requirements are met.
4. 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.
5. Kit, automation and service responsibilities including RA oversight and planning regarding site transfers, maintaining necessary establishment registrations, device listings, site certifications and US state licenses.
6. 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.
7. Managing Notified Body (and Competent Authority / UK MHRA) interactions and contract management to enable transition to IVDR (and UK equivalent) in the EU/UK.
8. 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
9. Manage other International regulatory agency interactions, together with all associated interactions with (including covering regulatory/quality requirements for) local representatives, agents, importers, distributors or OI offices / subsidiaries to effect and maintain regulatory approvals in those markets.
Specific deliverables for the role are:
1. Define regulatory strategy to ensure that eventual product approvals meet the company’s commercial needs with regards to TBand other related businesses or acquired businesses.
2. Manage all interactions with key regulatory bodies (Notified Bodies, MHRA, HPRA, CDRH and others) with respect to TB products and services.
3. Prepare EU CE Mark technical documentation (and UK equivalent), US FDA submissions (including pre submissions, pre-market notifications, pre-market approvals, etc.) and other regulatory submissions and manage the submissions / review process with the respective regulatory authorities through to completion (approval, clearance, etc., as appropriate).
4. Ensure all existing US FDA approvals / clearances are maintained appropriately and any product, system, software or other changes are appropriately reported and/or submitted for the appropriate approval, clearance or notification, as appropriate.
5. 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.
6. Work closely alongside RA and QA colleagues to ensure that actions are consistent with the Company’s overall regulatory strategy and quality policy / objectives.
7. Work with the relevant groups to ensure manufacturing/product development/scale up activities meet risk management and design control requirements; regulatory processes are followed correctly and that technical documentation, design history files, manufacturing batch records, quality documentation, risk assessments, etc., meet FDA requirements, QSRs and standards.
8. Ensure ongoing regulatory compliance post licensure / post approval.
9. Ensure OI’s QMS is adequate to enable approval / clearance and continued approval / clearance (certification / registration) of all IVD / medical device products, systems, services and for continued registration/certification of all sites and facilities.
10. 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.
11. 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.
12. Adhere to the Company Quality Management System(s), including those covered by: MDSAP, ISO 13485:2016, FDA QSR’s, Chinese NMPA GMP. Brazilian GMP, Korean GMP and all other respective QMS / regulatory requirements or standards.
13. Work to Oxford Immunotec’s Company Values at all times.
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
• 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
• Comfortable with a dynamic and changing environment, preferably with experience in IVD kits, instrumentation, software and automation.
• 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.
Emotional skills and abilities
• Advanced interpersonal skills which allow effective interaction and influence at all levels both internally and externally
• Being able to see the big picture, whilst also having a commitment to excellence and attention to detail
• Strong analytical skills
• Effective negotiation capability
• Highly intelligent and quick to learn
• Must have ability to work in a medium-sized company environment
• Proactive and willing to do things themselves
• Courage and creativity to challenge the established way of doing thing