full time legal

Job Details

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Summary

Our client is looking for a well-rounded Quality & Regulatory Affairs Specialist to join their growing team in Burlington. This individual will mostly be responsible for Post-market activities including complaint handling, MDR, and Customer Complaints.

Client Details

Our client is an oral health care company that delivers advanced, easy-to-use implants, biomaterials and planning software for dental professionals focused on providing the most functional and most aesthetically pleasing outcomes possible.

Description

The key responsibilities of are:the Sr... Regulatory Affairs Specialist are:

  • Applies knowledge of device regulatory requirements (FDA and/or other International Regulatory Agencies) to support the Post Market Surveillance MDR/ADE reporting process.
  • Examine complaint data to determine trends that may result in corrective action, report complaint trends to management and assist in post market compliance activities, including field safety corrective actions/recalls related to complaints.
  • Receive, review and conduct investigations of escalated product complaints or assigned product quality issues, from data collection to investigation summary, including coordinating implementation or recommendation of follow-on quality system activities

Profile

The successful Quality & Regulatory Specialist are:

  • BS Degree
  • 3+ years of experience
  • Experience with MDR
  • Heavy experience with customer complaints and Post Market Surveillance

Job Offer

Our client offers a base salary with strong benefits and the flexibility to work from home

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