Regulatory Affairs Manager (f/m)

Switzerland  ‐ Vor Ort
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Beschreibung

Regulatory Affairs Manager (f/m) & Regulatory Affairs Specialist (f/m)

For our client, a market leader in the Medical Device industry, I am currently selecting Regulatory Affairs Experts who can support the RA department with product development activities.

Responsibilities:
  • Development and execution of regulatory strategies for assigned projects
  • Responsibility for all RA deliverables linked to the management of new product development activities
  • 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)
  • Minimum of 5-10 years of experience in the Medical Device industry
  • Deep knowledge of ISO 13485, 21 CFR 820, current EU MDR & MDD
  • Has ideally already 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 (but also class II device experience is sufficient)
  • Excellent English skills


Key facts:
  • Start Date:
  • Length: at least 1 year
  • 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
T:
E:

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
07/2019
Dauer
1 year
Von
Real Staffing
Eingestellt
21.06.2019
Projekt-ID:
1787627
Vertragsart
Freiberuflich
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