Beschreibung
Are you an experienced Regulatory Affairs expert (m/f/d) looking for a new project? Our client, a large medical device company offers an interesting and exciting opportunity for freelance or contract Regulatory Affairs Specialist (m/f/d).Your role as Regulatory Affairs Specialist (m/f/d)
Support the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to:
- European Council Directive 92/42/EEC or Regulation , as applicable,
- US FDA 510(k) submissions or Notes to file, as applicable
- As well as country registrations on a world-wide basis, as appropriate.
in the context of Life Cycle Management projects (e.g. change of manufacturing process and/or equipment, change of manufacturing site, etc.).
RESPONSIBILITIES
- Ensuring that the company's products comply with the regulations set up by government agencies
- Advising engineering and other support functions, as well as manufacturing on regulatory requirements
- Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities
- Creating, reviewing and maintaining regulatory related technical documentation
- Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
Required skills
- 5 years of experience in European Medical device industry especially with regulatory, quality or engineering
- Strong knowledge of
o ISO 13485 and ISO 9001, QSR
o Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation , as they pertain to technical documentation
o MEDDEV guidance documents applicable to Medical Devices products and processes - Reasonable knowledge of
o FDA requirements
o registration requirements in further global markets would be an asset - Strong understanding of Risk Management process, label and labeling, change management is desired
Further information
- Start date: ideally or
- Duration: 12 months, with high chance of extension
- Location: Switzerland, Zuchwil
- Workload: 100 %
- Remote/ On-Site: Some remote is possible
- Language: English fluent, German is a plus
- Work-Allowance: You need to have Swiss nationality, Swiss work permit or EU passport
Interested?
If you would like to apply for this medical device project as a LCM Regulatory Affairs Specialist please contact me via phone for more information. Or you can apply directly by clicking the Apply button.
We are looking forward to your application.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.