Regulatory Affairs Manager (f/m)

This job has now expired please search on the home page to find live IT Jobs.

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.