ProClinical has a new open position for a Regulatory Affairs Specialist to join a project to support technical files remediation. This is a contract role based in Switzerland.
- Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation
- Reviewing of Risk Management Documentation according to EN ISO 14971:2012 with respect to regulatory requirements.
- Reviewing of labeling and promotion material for accuracy and consistency.
- Ensuring that the company's products comply with the regulations of government agencies, including but not limited to:
- Keeping abreast of international legislation, guidelines and customer practices.
- Collecting and collating a wide range of information.
- Keeping up to date with a company's product range.
- Developing and writing clear arguments and explanations for regulatory documentation
- Advising scientists and manufacturers on regulatory requirements.
- Reviewing change requests
- Reviewing, preparing and coordinating documentation.
- Reviewing company practices and providing advice on changes to systems.
- Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
- Experience with Risk Management documentation for medical devices according to EN ISO 14971:2012
- 2-3 years of experience in Medical Device Regulatory
- Familiarity with Technical Documentation structure according to STED
- Technically versed in computer software such as MS Word, Excel, Powerpoint,
- This contract role is till the end of the year.
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 Beata Klecz on +44 203 0789 551 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.