21 days ago

Global Regulatory Affairs Manager Healthcare (m/f) 100%

Medela AG

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At our headquarters in Baar, we are seeking for the Global Regulatory Affairs department a

Global Regulatory Affairs Manager Healthcare (m/f) 100%

  • Assists in the development of worldwide regulatory strategies and filings for product approvals
  • Provide regulatory support and guidance to cross-functional project teams in conjunction with direct manager
  • On a project team, makes decisions involving worldwide submissions and provides advice and counsel to other team members in terms of applicable standards and guidance in e.g. within product development projects
  • Coordinate, assist and/or prepare and submit FDA submissions
  • Support technical Audit in terms of IEC 60601-1, EMV, environmental and package testing
  • Responsible to coordinate, assist and/or prepare dossiers for worldwide submissions as well as management and coordination of the registration process until receipt of certificate (e.g. EU, USA, China, Japan, Canada, Latin American Countries, Middle Eastern Countries)
  • Reviews and approves change requests and implements necessary action to already registered products worldwide
  • Maintains current knowledge of FDA, European and Worldwide Regulatory Authority programs, standards and guidelines in terms of Active and non-active medical devices
  • Assures that all submission documentation, record keeping and reporting meet inspection standards as established by regulatory agencies worldwide
  • Assist in the process for the development and release of labeling/marketing materials (Instructions for Use, labels, brochures) intended for users like mothers,patients and health professionals
  • Ensures all labeling materials are designed in accordance with worldwide regulatory requirements and company standards
  • BS degree in health or science-related field, or equivalent (e.g. technical education)
  • Minimum of 5 year`s experience in Regulatory Affairs in medical device industry (active and non-active medical devices)
  • Excellent verbal, written and organizational skills
  • Good computer skills
  • Must be detail-oriented
  • Good English and German writing and speaking skills

At Medela, you will be joining a global community of colleagues, united by the purpose that drives our business: helping people. Through our range of offerings, we deliver care and support to people throughout their lives. Our employees are empowered to serve this purpose in a family-owned company that is growing rapidly around the world. We value intensive exchanges, diverse perspectives, and unbureaucratic decisions. You will have the opportunity to develop at an international level, and witness the direct impact your work has on our company’s success.

If you are interested in this opportunity, Diana Krnja, Head of Recruitment & Employer Branding, is looking forward to receiving your application.

Medela AG
Diana Krnja
Lättichstrasse 4b
6340 Baar