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Senior Regulatory and Clinical Lead
4 months ago
Senior Regulatory Affairs and Clinical LeadnJob Type:
Full-time, permanent positionnLocation:
West Oxfordshire, (On-site)nRemuneration:
£100,000 +
This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home and hospital settings.
With a diverse, global network serving customers in more than 160 countries, the organisation creates new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, the business is advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The business is currently looking for a Senior Regulatory Strategy Lead to join the team and take the lead on developing, creating, and implementing regulatory strategies for developing and establishing medical devices.
Key ResponsibilitiesnDrive robust regulatory strategies for both developing and established devices ensuring all regulations are adhered to at both local and global levels.nLead all interactions with notified bodies, drive pre-submission meetings and support all cross-functional team.nSupport in both aspects of regulatory and clinical including CTAs, clinical and non-clinical.nLead a team of mixed-ability professionals in both regulatory and clinical offering training, development, and mentoring.nProvide strategic input and technical guidance on regulatory authority queries.nOversee processes involved with maintaining annual licenses, registrations, listings, and patent information.nDevelop global regulatory strategies and update them based upon regulatory changes.nConduct regulatory due diligence for potential and new acquisitions and advise management.nUtilize technical regulatory skills to propose strategies on complex issues.nLead crisis management program development and implementation.nApprove regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges.nLead processes and team involved with obtaining and maintaining product registration, release authorization, and release of products to specified geographies.nDrive regulatory strategies including working cross-functionally with other departments to ensure the right strategy is defined.nProvide training and mentoring to junior colleagues with the scope to get into line management depending on the individual's preference.nInteract with notified bodies and keep well-versed in global regulations.
RequirementsnUniversity degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering, or equivalent experience.nPrevious line management experience managing a broad range of individuals at all levels.nNon clinical and clinical experience and being able to input into both RA and Clinical.nPrevious experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).nLead strategies for a large product portfolio including supporting new registrations, authoring technical files, and post-market surveillance.nA minimum of 8 years post-qualification experience in regulatory affairs in the medical device and/or pharmaceutical industry in product registration, medical device file, and/or technical compliance activities.
Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organsiation offers a highly attractive benefits package that includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements.
If you are interested in this role or would like more details please email your CV
