Regulatory Affairs Manager

• 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

• 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