My client, an Oxfordshire based biotech, is looking for a Director of Regulatory Affairs on a permanent basis. This is paying up to £107,000 plus bonus/pensions and healthcare.
This position is responsible for the direction and management of regulatory activities within 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.
If of interest, please apply and get in touch with Ross Wilson at email@example.com for further information.