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Complaint Handler – 990057

Burlington, MA

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Our client is seeking Post Market Surveillance Analyst in the Boston Area!

Our client is one of the largest providers of medical devices, with a focus on implants to treat peripheral vascular disease. They are creating innovative disposable and implantable vascular devices to address patient needs. This company is changing the way medical devices are used since 1983.

Specific Responsibilities:

  • Process complaints and regulatory reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed
  • Interface directly with internal and external customers and regulatory agencies as required
  • Prepare and contribute to responses to regulatory inquires as needed
  • Support quality metrics development and monitoring, participating in regular business and quality system performance reviews
  • Review complaint data and prepare reports for internal customers as needed.
  • Provide support for other Quality functions as needed, including field actions, corrective actions, and others.
  • Carry out the requirements of the company’s quality system.

Qualifications:

  • BS with 2+ years in the medical device or biotechnology industry
  • In-depth knowledge and understanding of regulatory agency (cGMP/ISO) requirements for complaint management
  • 1+ years complaint handling experience including initiation through closure
  • 1+ years independent post-market regulatory reporting experience (MDR and/or Vigilance), drafting and submitting
  • Located in, or willing to relocate to, Burlington, MA