Manager, Global Vigilance Writing (Hybrid - Acton, MA)
$112,300–$168,400 year
Hybrid · Acton, Massachusetts, United States
Job Summary
Lead the Post Market Surveillance lab as a hands-on engineering manager: oversee the complaint lab team, manage investigations from initiation to closure, ensure timely resolution meeting regulatory and customer requirements, provide feedback and training on write-ups, drive KPIs for throughput and complaint rate, collaborate with R&D, Operations, and QA to determine root causes, and promote continuous improvement through standard practices. Must adhere to regulatory requirements (FDA and others) and prepare responses to competent authorities. Ability to supervise and mentor a multi-disciplinary team and maintain organized records. Travel may be required; hybrid on-site work at an Insulet office is noted.
Required Qualifications
- BS/BA degree in engineering
- Demonstrated people management experience leading teams of 5 or more technical employees
- 8+ years of experience in the field with 5 or more years of related experience in medical device complaint processes
- 3-5 years of people manager / supervisory experience
- Knowledge of Regulatory and Quality Management skills
- Effective verbal and excellent technical writing skills
- Ability to communicate and work effectively within the organization
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