ProClinical is seeking a Regulatory Affairs Specialist who will support marketing authorization, product development and compliance and vigilance for mechatronic devices within a life science consulting company. This role will be based in Vaud, Switzerland, on a contract basis.
- Contribute to product development, compliance and vigilance of mechatronic devices
- Collaborate with cross functional teams to support the development of pre and postmarking activities on a Global scale
- Keep up to date with regulatory requirements and maintain regulatory files like 510k and EC Technical files
- Maintain pre-clinical data, clinical data and sterilization files
- Support and participate in inspections and audits (notified body, FDA, Korea etc.)
- Responsible for preparation and maintenance of 510K files for FDA reviews and approvals
- Support the development and maintenance of risk management files
- Support the maintenance and update and ladling and artwork
- Support post market vigilance activities related to product line
Skills and Requirements:
- Minimum 2 years' experience in Medical Device Regulatory Affairs
- Degree in relevant subject (Engineering or related)
- Knowledge of medical device regulations and guidelines
- Strong communication abilities in English, ability to speak another EU language is a bonus e.g. French
- Strong Knowledge MS Office
- Knowledge of track wise (a bonus)
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 Amie Touray on +44 203 814 1317 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.