Hobson Prior are looking for a Director of Regulatory Affairs to join a top biotechnology organisation on a permanent basis in Hertfordshire. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life. This position will be accountable for all aspects of regulatory affairs relating to in-vitro medical devices/diagnostics in all territories in which the company operates.
- Accountable for establishing and implementing the global regulatory diagnostics strategy which is aligned with the co-development and commercialization strategies of the gene therapies concerned in key markets including EU and US.
- Deliver strategic direction and operational regulatory support as the Functional Lead on the project teams and other groups within company as required.
- Manages submission activities for a variety of device regulatory approvals including CE marks, Q-submissions (including briefing books), US premarket approvals, US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
- Review, interpret, and report on product specific regulatory issues including evolving regulatory intelligence that may have material impact on the business units, the corporation, or the customer to the Regulatory leadership and concerned Regulatory Gene Therapy Product Leads.
- Provides support to marketed products, e.g., review engineering changes, labelling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to EU, US and international regulatory requirements.
- Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations and maintenance of international regulatory approvals to market devices.
- You will lead and manage interactions with Regulatory Authorities/Stakeholders as appropriate.
- Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
- Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department
- Training staff in regulatory matters as required.
- Excellent communication skills
- Excellent presentation skills
- Ability to create and drive an effective regulatory strategy to support commercialization.
- Ability to handle critical issue effectively with demonstrated creativity in solving regulatory issues.
- Bachelor’s degree in science, engineering, or related technical field; advanced degree preferred.
- At least 5 to 7 years’ experience in regulatory IVD preferably in EU + US where EU is a minimum.
- Previous experience with Microsoft based applications and general knowledge of PC functions necessary.
- Proven experience in managing budgets and vendors is preferred.
- Experience with regulatory submissions including CE-marking, clinical trial notifications, IDE, 510(k), and PMA submissions.
- Awareness of IND, NDA/BLA, CTA and MAA as a minimum.
- Experience in diagnostics or biomarker development with emphasis on gene therapy/oncology a plus.
- Experience of planning and leading meetings with the key regulatory stakeholders e.g. FDA, Notified Bodies and CLIA.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.