Category

Description

• Carry out responsibilities of the Office of Authorised Representative (AR
• Verifying compliance on behalf of AR Clients with regulations, standards and guidance documents
• Maintaining and developing processes and procedures in support of the role of European AR
• Liaising with and responding to requests for information and/ or documentation from Competent Authorities (CA's)
• Carry out responsibilities in support of full global regulatory submissions
• Providing regulatory advice and guidance to Sponsors and other departments to ensure compliance with regulations, standards and guidance documents
• Developing scientific and regulatory briefing documents for meetings with the regulatory agencies and bodies
• Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

• Eligible to work in the UK
• Bachelor's degree, preferably in the sciences, or equivalent experience qualification
• Minimum five years medical device, in vitro diagnostic and/ or active implantable experience within Regulatory Affairs or in a similar role
• Demonstrable experience, including document preparation and/ or writing, clinical trials, post-market activities and regulatory agency interaction
• Knowledge of existing medical devices regulations is essential with knowledge of new medical device regulations being highly desirable
• Experience with regulatory agencies and notified bodies is preferred
• Strong computer skills, project management skills, and a high attention to detail
• Strong communication skills (both written and oral)

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