Regulatory Affairs Specialist

Regulatory Affairs Specialist
In Caledonia, Michigan 49316

Job Description

Workway is a professional staffing firm, working with organizations across the country to place exceptional candidates. We are looking for a Regulatory Affairs Specialist responsible to erforms regulatory assessment on all customer complaints.  

Your specific duties will include:

  • Reviews technical publications and revisions to standards to ensure compliance with regulatory and industry standards
  • Supports international registration activities required by our customers or international distributors
  • Reviews and approves sales and marketing literature to ensure regulatory compliance
  • Assist with annual Regulatory activities (FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses, CFG)

Specific qualifications for the position include

  • Quality System knowledge including the quality manual, quality policy, and applicable procedures and work instructions
  • Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulations, ISO 13485, European Union Medical Device Directives, Japanese Ministry of Health and Welfare, and Canadian Medical Device Regulations
  • Completes and documents all required quality, business, and departmental training

Let one of our recruiters assist you in finding and preparing for interviews with our clients. Whether you are interested in a direct hire, temp-to-hire, or temporary position, Workway can help you to put your best foot forward. Contact us today! 

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Abhijeet Pathak
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703-889-6814