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Regulatory Affairs Manager

Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: Zürich, Switzerland
Industry:
Salary: Negotiable
Reference: HQ00112707_1573742731
Contact Name: Michael Burgstaller
Contact Email: m.burgstaller@sciproglobal.de
Job Published: November 14, 2019 14:45

Job Description

Our Client:

A company in the Swiss town of Bülach, Zürich, focused on the development and manufacturing of guide wires, stents and balloon catheters for the treatment of cardiovascular and endovascular diseases. With newly developed class III innovative products, the Regulatory Affairs department offers a great opportunity to work on truly challenging regulatory submissions.

Job Description:

  • Assessing and clarifying the requirements for new Vascular Intervention device registrations and the regulatory relevance of changes
  • Supporting submissions by preparing and providing requested documentation and responses to deficiencies in a timely manner and to achieve registrations in assigned countries
  • Coordinating activities in relation to the registration of products from other manufacturers distributed by Biotronik
  • Maintaining project status of country registrations in the regulatory database

The ideal candidate:

  • University degree in natural sciences, engineering or equivalent background
  • Relevant and direct work experience in regulatory affairs in a medical device company operating on a global scale
  • Worldwide experience in the registration of high-risk medical devices (class III and IV) with emphasis on the APAC region
  • Independent, reliable and communicative personality which is able to deliver high-quality work and to handle a high number of projects simultaneously
  • Microsoft office applications, registration databases and SAP user
  • Fluency in English and German; any additional language is welcome

Application process:

  • CV to: m.burgstaller@sciproglobal.de
  • Phone call including a presentation of the company
  • I take over the whole application process (from interviews to contract negotiations)
  • Discuss also other suiting options tailored towards your profile

My Contact: