Regulatory Consultant

Proclinical is seeking a Regulatory Partner to join a dynamic team. This role is focused on translating the evolving requirements of the UK Regulatory environment into policies, procedures, solutions and strategies that ensure compliance and maximise patient value. The successful candidate will be part of a team that is committed to creating a more open, dynamic, transparent, inclusive, collaborative and agile business environment.

Responsibilities:

• Support the team in ensuring regulatory requirements are met for Clinical Trial Applications involving Medical Devices.
• Monitor changes to the UK Regulatory environment and provide impact assessments on changes to the current framework or implementation of new regulations.
• Participate in Trade Associations working groups and gather regulatory intelligence.
• Provide support for the implementation and adaptation of the medical device structure across the UK Affiliate.
• Provide regulatory advice to project teams to ensure continued regulatory compliance and timely market release.
• Support external regulatory agency audits, providing regulatory input to minimise potential for findings of non-compliance.
• Advise manufacturers/global team to obtain and maintain a UKCA mark and any relevant regulatory milestone concerning the UK.
• Provide training on medical device regulation and its related aspects.
• Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information.
• Review product and process documentation for assigned projects to ensure compliance with requirements.
• Act as liaison between multiple project teams to obtain significant information and answer queries.

Key Skills and Requirements:

• A scientific degree is required.
• Understanding of the medical devices industry and experience working within a regulated environment.
• Broad regulatory background and experience.
• Ability to understand scientific and technical information relating to an assigned portfolio of products.
• Strong communication and collaboration skills.

Interested or know someone who might be? Reach out to Caitlin Siljeur using the following:

✉️ c.siljeur@proclinical.com

📞 020 3148 8378

Apply Now:

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.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.