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Regulatory Affairs Manager - Switzerland

Regulatory Affairs Manager - Switzerland

  • Location

    Basel, Switzerland

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    90.000 - 120.000 CHF

  • Contact:

    Callum Sparkes

  • Job ref:

    39283

  • Published:

    about 1 year ago

  • Expiry date:

    2019-05-19

  • Consultant:

    #

Are you looking to develop your skills in an exciting and growing implants company that focus on facilitating the career growth of their employees?

Do you have experience in Medical Devices Regulatory Affairs and want to develop those skills further?

Then why not apply for this Regulatory Affairs Manager position and see where you can progress!

Tasks:

  • 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 life cycle 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

Your Profile:

  • 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
  • Your Perspectives:
  • Challenging work in an exciting environment
  • International employer with team-oriented working atmosphere
  • Attractive conditions of employment