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Regulatory Affairs Manager (Basel/CH)

Regulatory Affairs Manager (Basel/CH)

Job Title: Regulatory Affairs Manager (Basel/CH)
Contract Type: Permanent
Location: Basel, Switzerland
Industry:
Salary: Swiss Franc120000 - Swiss Franc140000 per annum
Reference: HQ00111885_1585820367
Contact Name: Michael Burgstaller
Contact Email: m.burgstaller@sciproglobal.de
Job Published: April 02, 2020 10:39

Job Description

Our Client:

A company in the Swiss town of Basel, focused on the production of innovative products for implant dentistry. To ensure a continuous technical and qualitative development of the products and processes, a new colleague for the team is needed:

Job Description:

  • Ensuring that regulatory requirements for the approval of medical devices are met during the product development process
  • Supporting and advising brand managers throughout the entire lifecycle of the products in regulatory terms and ensuring that the technical documentation of the products complies with the regulatory requirements for medical devices
  • Assessment of all products with regard to their risk potential
  • Responsibility for the regulatory content of product-related information and its release
  • Conducting conformity assessment procedures for the products and initiating the preparation of the declaration of conformity
  • Market release of medical devices
  • Support of international registration submissions
  • Support in the preparation and execution of audits
  • Support and consulting for research & development and brand management in the interpretation of regulatory requirements
  • Communication of new regulatory approval requirements to research & development as well as brand management and support in the implementation thereof
  • Participation in the respective product development teams

The ideal candidate:

  • Scientific studies, or studies in engineering, or studies in the field of medicine, or corresponding industry experience
  • 3 years experience in regulatory affairs and in international approvals in the fields of medical technology or pharmaceuticals, experience in quality management and / or product development is an advantage
  • Knowledge of MDD 93/42/EEC (product classification, definition of applicable standards, conformity assessment procedures) and other relevant regulations (e.g. the future MDR 2017/745)
  • Experience in working in interdisciplinary teams
  • Excellent MS-Office knowledge, experience in handling document control and / or ERP systems (e.g. SAP) is an advantage
  • German and English proficiency written and spoken, additional languages are an advantage

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:

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