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Regulatory Affairs Manager (f/m)

  • Job type Contract
  • Salary competitive
  • Location Switzerland, Switzerland
  • Sector Medical Devices

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: 04/2019
  • 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: +41 (0) 44 588 2619
E: e.bollinger(at)realstaffing.com

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.