Product Complaint Manager

Boston Scientific Foundation Inc

Arden Hills, MN, US
Base: $102,100 - $194,000; bonus/equity: annual bo...
On-site
Manage post market surveillance staff
Ensure fda cfr part 820 compliance
Investigate product complaints reportability
This role is responsible for managing the Post Market Surveillance staff and ensuring all complaint handling activities comply with corporate, domestic, and international regulations

Job Summary

  • This role is responsible for managing the Post Market Surveillance staff and ensuring all complaint handling activities comply with corporate, domestic, and international regulations.
  • The position requires escalating and participating in the resolution of potential product deficiencies while serving as a quality liaison between business units.
  • Candidates must ensure site operational procedures align with corporate policies and FDA regulations including CFR Part 820 and 803.

Matching Summary

This role is responsible for managing the Post Market Surveillance staff and ensuring all complaint handling activities comply with corporate, domestic, and international regulations.

Salary

Base: $102,100 - $194,000; Bonus/Equity: Annual bonus target and long-term incentives available for exempt roles; Benefits: Core and optional employee benefits offered per bscbenefitsconnect.com

Skills & Requirements

Must-have

  • Manage Post Market Surveillance staff
  • Ensure FDA CFR Part 820 compliance
  • Investigate product complaints reportability
  • Implement corrective and preventive actions
  • Coordinate with domestic and international auditors

Nice-to-have

  • Experience with CRM products
  • Vendor management experience
  • Strong project management skills
  • Boston Scientific internal experience
  • Effective team leadership capabilities

Key Requirements

  • Bachelor's Degree required
  • Minimum 5 years related work experience
  • Knowledge of US and international regulatory reporting requirements

Work Rights

Not specified

Tailored Resume

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