Medical Device Compliance Specialist

Vor 2 Tagen


Zürich, Zürich, Schweiz elemed Vollzeit
Key Responsibilities
  • Management of technical documentation on an international scale.
  • Maintain the CE mark and PMA.
  • Act as the point of contact with notified bodies and health authorities.
  • Work closely with the VP RA/QA and Director of RA/QA to support all maintenance activities for regulatory affairs.
  • Manage design control meetings and activities such as creating and maintaining technical documentation, DHFs, DMRs.
  • Advise during development and remediation projects from a regulatory perspective.
  • Support activities related to electrical safety and software.
  • Lead change management activities.


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