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

Insulet Corporation•Acton, MA

2d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree and demonstrated 5+ years’ experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support or appropriate combination of relevant education and experience preferred.
Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work.
Effective verbal and written communication skills.
Proven experience to organize, prioritize, and follow through on multiple tasks with minimal supervision.
Demonstrated medical device complaint handling and vigilance reporting experience.
Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements.
Direct experience in writing and filing global vigilance reports within the medical device industry.
Experience in dealing directly with regulatory bodies is highly desired.
Strong emphasis and understanding of a formalized medical device Quality Management System and regulatory framework.
Ability to generate, verify, and maintain accurate records.
Must have analytical skills, be detail oriented, and have good interpersonal skills.
Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.

Nice To Haves

BSN with diabetes experience, Registered or Licensed Dietician, or Diabetic Educator, preferred.

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 staff as applicable to review events, coding, and investigation results to support regulatory reporting compliance ensuring it occurs per procedures, standards, and regulations.
Support and/or lead departmental non-conformances, events, and CAPAs.
Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries.
Support internal and external audits and inspections.
Support and/or lead departmental critical initiatives or special projects, as assigned, with minimal supervision.
Perform other duties as assigned.