Regulatory Start-up Manager - Medical devices experience needed
A new job opportunity has arisen for a Regulatory Start-Up Manager position for a scientifically-driven, global, full-service clinical contract research organization. The company focuses on accelerating the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach, and is seeking for a Regulatory Start-Up Manager to join their Clinical Operations team in London.
The Regulatory Start-Up Manager will play a key role in the clinical trial management process at the company, and will be called upon to use their previous expertise to develop their career in the clinical research field.
- Efficiently managing and successfully executing all aspects of global device trial start-ups, according to sponsor specifications.
- Overseeing regional and/or global operation teams and preparing submission packets.
- Preparing and/or reviewing documents for RA and EC submission packages.
- Reviewing pertinent regulations to develop proactive solutions to stay-up issues and challenges.
- Providing advice to sponsors and project teams on device regulations and strategies.
- Presenting during bid defences, general capabilities meetings, and audits.
Skills and Requirements:
- A bachelor's in a life sciences degree.
- More than 5 years of experience in devices-based clinical research.
- Demonstrable knowledge and experience with Device Clinical Trial Applications within Europe.
- Knowledge and experience of Pharmaceutical Clinical Trial Applications within Europe an advantage.
- Strong written and verbal communication skills, with good-team interpersonal skills.
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 call Theodora Savlovschi-Wicks on +44 203 752 0314 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.
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