01 Oct
Regulatory Affairs Consultant
Washington, Bothell , 98011 Bothell USA

Vacancy expired!

Job Description:

  • Working as part of our Regulatory Affairs department for

    Medical Devices, as Regulatory Affairs Specialist you will be working with manufacturing clients offering regulatory expertise. This is an exciting role where you’ll be given opportunities to further develop your knowledge of global regulations.
Responsibilities:
  • Prepares and submits registrations and CE mark documents.
  • May handle or support requests for testing from country and/or regulatory agencies, prepare and submit product test requests and submissions to regulatory bodies.
  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Develop and prepare safety and compliance test requests for US, Canada, EU and select worldwide locations.
  • Review and approve engineering changes and labeling for regulatory compliance.
  • Identify potential regulatory approval risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
Required Experience:
  • Minimum 2-5 years professional experience of regulatory affairs within medical devices
  • Familiar with electrical safety and compliance test methodologies and with maintaining files and communicating changes in an evolving regulatory landscape.
  • Familiar with quality system requirements.
Terminology Definitions“CE Mark”The letters 'CE' appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.

Vacancy expired!


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