Beschreibung
Regulatory Affairs Manager (f/m)For our client, a market leader in the Medical Device industry, I am currently selecting Regulatory Affairs Experts who can support with the development and execution of regulatory strategies.
Responsibilities:
- Development and execution of regulatory strategies for assigned projects
- Support product registrations (CE marking, 510k and Canada submissions)
- Monitoring of submission timelines
- Communication with notified bodies or competent authorities
- Creation, review and approval of documents for the design control process; summary of technical documentation
- Strong cooperation with product development team to ensure compliance and timely market release of products
- 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)
Qualifications:
- Higher education (preferably engineering or science)
- At least 5-10 years of experience in the Medical Device industry
- Deep knowledge of ISO 13485, 21 CFR 820, current EU MDR & MDD
- International registration experience (EU, US and Canada)
- Preferably experience working with or for EU-MDR Authorities/EU-MDR commission or Notified Bodies
- Preferably experience with class III medical devices
- Excellent English skills
Key facts:
- Start Date:
- Length: 6 months (potential extension)
- Workload: 100%
- Location: Central Switzerland
Are you looking for a new challenge within Regulatory Affairs by working for an international, well-known medical device company? Then we are looking forward to receive your updated CV!
Consultant Details:
Elena Bollinger
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.