Senior Regulatory Manager, Clinical Affairs

4 weeks ago

Oxford, United Kingdom Cpl Life Sciences Full time

Job Title: Senior Regulatory Affairs and Clinical Lead

Job Type: Full time, permanent position

Location: West Oxfordshire, (On-site)

Remuneration: £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 Responsibilities

·       Drive robust regulatory strategies for both developing and established devices ensuring all regulations are adhered to at both local and global levels. 

·       Lead all interactions with notified bodies, drive pre-submission meetings and support all cross-functional team.

·       Support in both aspects of regulatory and clinical including CTAs, clinical and non-clinical.

·       Lead a team of mixed-ability professionals in both regulatory and clinical offering training, development, and mentoring.  

·       Provide strategic input and technical guidance on regulatory authority queries.

·       Oversee processes involved with maintaining annual licenses, registrations, listings, and patent information.

·       Develop global regulatory strategies and update them based upon regulatory changes.

·       Conduct regulatory due diligence for potential and new acquisitions and advise management.

·       Utilize technical regulatory skills to propose strategies on complex issues.

·       Lead crisis management program development and implementation.

·       Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges.

·       Lead processes and team involved with obtaining and maintaining product registration, release authorization, and release of products to specified geographies.

·       Drive regulatory strategies including working cross-functionally with other departments to ensure the right strategy is defined.

·       Provide training and mentoring to junior colleagues with the scope to get into line management depending on the individual's preference.

·       Interact with notified bodies and keep well-versed in global regulations.

Requirements

·       University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering, or equivalent experience.

·       Previous line management experience managing a broad range of individuals at all levels.

·       Non clinical and clinical experience and being able to input into both RA and Clinical.

·       Experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).

·       Previous lead strategies for a large product portfolio including supporting new registrations, authoring technical files, and post-market surveillance.

·       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

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