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.
- 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)
- 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
- 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!
T: +41 (0) 44 588 2619
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.