Senior Product Complaint Manager

3 weeks ago


Maple Grove, Minnesota, United States Boston Scientific Full time
About the Role

The Senior Product Complaint Manager will be responsible for planning, developing, and maintaining Post Market Surveillance compliance programs for the Cardiovascular Complaint Management Center supporting the Interventional Cardiology division.

Key Responsibilities
  • Operational accountability over understanding, documenting, and communicating device performance through timely capture of field performance inputs, comprehensive investigation, and analysis of relevant supporting data.
  • Consistent assessment of reporting obligations across all teams in accordance with evolving worldwide regulations.
  • Effective, timely correspondence with customers and worldwide regulatory agencies.
  • Strong partnership with divisional and global Quality/Regulatory and other stakeholders to communicate overall product performance aligned with clinical and risk management product profiles.
  • Establish and ensure compliance with applicable global regulations, company, and department policies and procedures.
Requirements
  • Minimum of a Bachelor's Degree.
  • Minimum of 10 years of related experience (complaint management, post market surveillance, quality systems).
  • Minimum of 3 years of management experience.
  • Medical device experience.
Preferred Qualifications
  • Proven leadership capabilities with a passion for developing others.
  • Strong communication and problem-solving skills.
  • High sense of urgency and commitment to execution.
  • Ability to make consequential decisions in a high-pressure environment, while engaging stakeholders.
  • Demonstrated high degree of integrity, professionalism, and ability to establish credibility internally and externally.


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