Manager, Global Vigilance Writing (Hybrid - Acton, MA)

The Manager, Global Vigilance Writing is a hands-on technical leader serving as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives supporting post-market vigilance. This role will provide direction to individuals who are responsible for the assessment, follow-up, coding, and vigilance activities for complaints determined to be reportable for the US FDA and other countries. The role requires strong organization skills and attention to detail while working in cross functional teams to accomplish departmental and company goals.  

Key Responsibilities: 

• Manage, mentor, provide direction to, and develop direct reports through reviews, meetings, and daily interactions to ensure the timely processing of customer complaints and adverse event reports in a face-paced work environment. 

• Provide coaching and feedback in accordance with company SMART goals.  

• Establish / Track daily team metrics to ensure performance targets are achieved. 

• Approve / Sign-off work of direct reports and other team members. 

• Support a positive culture with clear communication regarding goals and objectives. 

• Provide input to management to define reports/dashboards to identify delinquency or backlog in all aspects of the vigilance process. 

• Collaborate with engineering, complaint investigation laboratory, medical, and other internal staff as applicable to review events, coding, and investigation results to support regulatory reporting compliance. 

• Author, peer review, and/or approve vigilance reports to ensure on time submissions to the appropriate regulatory authorities, as applicable. 

• Collaborate with engineering, complaint investigation laboratory, medical, and other internal staf