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Regulatory Affairs Manager

Location Basel, Switzerland
Sector
Job type Permanent
Salary Negotiable
Start date ASAP
Contact Michael Burgstaller
Job ref ID 2083_1592486430

Job description

Wir unterstützen unseren Schweizer Partner dabei für einen Schweizer Kunden einen Regulatory Affairs Manager zu suchen!

The Client:

An outstanding Swiss Medtech Company.

Your 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
    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
Your Qualifications:

  • Scientifi c studies, or studies in
    engineering, or studies in the fi eld of
    medicine, or corresponding industry
    experience
  • 3 years experience in regulatory aff airs
    and in international approvals in
    the fi elds of medical technology or
    pharmaceuticals, experience in quality
    management and / or product
    development is an advantage
  • Knowledge of MDD 93/42/EEC (product
    classifi cation, defi nition 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-Offi ce knowledge,
    experience in handling document
    control and / or ERP systems (e.g. SAP)
    is an advantage
  • German and English profi ciency written
    and spoken, additional languages
    are an advantage

Contact:

m.burgstaller@sciproglobal.de

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