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Current Openings

Regulatory Compliance Director, Kent Imaging Inc.

Reports To: CEO

Job Overview: The Regulatory Compliance Director will play a crucial and central role within Kent Imaging, maintaining and implementing processes to support regulatory compliance. This role will oversee the ongoing implementation of a regulatory software platform, and the submission of applications for obtaining regulatory clearance for Kent’s products in multiple jurisdictions.

Responsibilities and Duties:

  • Successful management of ISO compliance for medical product (ISO 13485)
  • Ongoing regular audits and corrective actions for ISO compliance
  • Identification, management and ownership of all company compliance processes
  • Act as a management representative on the Management team
  • Writing and maintenance of compliance documentation
  • Control of all quality documentation, or implementation of and management of a document control system for a medical device
  • Knowledge and ownership of certifications for electronic medical device sales in North America and the EU
  • Ownership and understanding of electronic medical device certifications for additional countries as required

 

Qualifications:

Must have:

  • Solid understanding of ISO13485, MDSAP and MDR guidelines and at least 5 years experience in implementing and supporting these guidelines for a medical system, product or process
  • Experience in conducting internal audits and identification of procedures that need improvement or modification to align with actual processes
  • Experience writing quality procedures
  • Experience in creating technical files for 510K submission to FDA
  • Experience in creating technical files and submissions for CE Marking
  • Highly organized
  • Document control and management experience; must have either implemented or know how to implement a document control system

 

To apply, send resume and cover letter to jobs@kentimaging.com