Senior Regulatory Affairs Specialist
A leading UK surgical robotics company is currently recruiting a Senior Regulatory Affairs Specialist to their Cambridge office. This is an exciting opportunity to become embedded in the wider regulatory affairs operations team and work on ground-breaking new developments.
- Assisting with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- Preparing document packages for regulatory submissions.
- Keeping abreast of regulatory procedures and changes.
- Reviewing proposed product changes for impact on their regulatory status.
- Communicating with regulatory and governmental agencies.
- Reviewing proposed labelling, promotion and advertising material for its compliance with applicable global regulations.
- Responding to requests from foreign government and/or distributors as needed.
Skills and Requirements:
- A degree or higher in a relevant life science, scientific or engineering-based discipline, but a combination of education and experience may be considered.
- A track record of successfully gaining regulatory approvals in various markets.
- Experience in the medical device industry.
- A strong attention to detail and the ability to multi-task and balance competing priorities.
- The ability to build relationships between Regulatory Affairs and other areas of the organisation and to communicate effectively at all levels.
- A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues.
- A thorough and sound working knowledge of regulatory compliance in Europe, USA, China and Japan.
- A willingness to turn your hand to anything within the Regulatory Affairs remit that helps the team deliver its objectives.
- Ability to travel occasionally when required.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Megan Lockey at 0203 854 2627 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.