Description
Regulatory Affairs Expert (RA Expert)For our client, a Market Leader in the Medical Device industry, I am currently selecting Regulatory Affairs Experts, in order to manage and work strategically on the transition to the new Medical Device Regulations (MDR).
Responsibilities:
- Ensuring that the company's products are compliant with the regulations of government agencies with a strong focus on the European Medical Device Regulations (MDR)
- Make sure that technical documentation is conform with current and new regulatory requirements
- Reviewing existing documents of the company according to the new MDR, such as Clinical Evaluation Reports, Risk Management Files, Standard Evaluations
- Developing and writing clear arguments and explanations for regulatory documentation
- Advising scientists and manufacturers on regulatory requirements, especially about changes caused by the MDR
- Reviewing company practices and providing advice on changes to systems
- Make sure that the medical devices are compliant with the product development process and with the applicable regulatory requirements
- Drawing on relevant expertise and information from internal and external sources, make a major contribution towards the preparation of regulatory documentation (e.g. technical files)
Qualifications:
- Higher education (preferably engineering or science)
- Minimum 10 years of experience in the Medical Device industry
- Deep knowledge of ISO 13485, 21 CFR 820, current EU MDR & MDD
- Preferably experience working with or for EU-MDR Authorities/EU-MDR commission or Notified Bodies
- Experience/deep understanding of the changes for the MDR
- Regulatory Affairs experience for modification of Technical files accordable to the new MDR
- Excellent English skills, good German skills
Key facts:
Start Date: January/February 2018
Length: minimum 12 months
Extension: possible
Location: Central Switzerland
Workload: 100%
Next steps:
If you are interested in discussing further details about this or similar positions, kindly contact me as soon as possible.
Best Regards
Elena Reeb
Recruitment Consultant Medical Devices
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.