Description
Our client is a large and well respected manufacturer of Medical Devices with an emphasis on Orthopaedics products. They are currently seeking a Regulatory Affairs Manager to support their internal Regulatory Affairs department.Duration :
Location: Basel Country
Daily tasks
- Create and maintenance Technical File documentation
- Reviewing of Risk Management Documentation according to EN ISO
- 14971:2012 with respect to regulatory 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 company practices and providing advice on changes to Systems
Requirements
- 1-2 years experience within a Technical Regulatory position ( Medical Devices/Pharma)
- English fluent , German is a plus
For more information on this vacancy, and also Freelancer Quality Management roles in Switzerland in the medical devices field, please contact Ms Burcu Parilti on , or email her your CV in WORD format to