Role details

Quality and Complaints Manager

Lawrence   •   USD85,000 - USD110,000   •  Permanent

Bullet points

  • ISO 13485 experience required
  • Complaints Hanling required

About Our Client

Our client is a well established medical device company that is publicly traded and located in northern MA. They are an international company with clients around the world. As a team, they boast work/life balance as one of the many perks of working here.

Job Description

The Quality and Complaints Manager will:

  • Manage Complaint Handling Team to ensure timely review and closure of complaints
  • Support the quality management system in accordance with FDA regulations
  • Develop and maintain internal operating policies and procedures relating to regulatory and quality activities
  • Support FDA and Health Canada inspection activities
  • Deputy Management Representative under ISO Standard and QSR Regulations
  • Responsible for company interaction with the FDA and Health Canada with regard to product clearance, approval, or licensing and establishment registration and device listing
  • Responsible for obtaining FDA and Health Canada clearance or approval for new products, new indications, and new claims in accordance with product launch time lines and global regulatory initiatives

The Successful Applicant

The Quality and Complaints Manager should possess:

  • BS in engineering or scientific discipline
  • 5+ years of quality and regulatory experience
  • ISO 13485 experience
  • Excellent written and oral presentation skills
  • Experience negotiating and interfacing with US FDA and Health Canada
  • Experience with US FDA and Health Canada inspections
  • Ability to travel domestically and internationally

What's on Offer

  • Highly supportive and collaborative team
  • Work/life balance
  • International company

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1187271
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