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

TheManager, Global Vigilance Writingisa hands-on technical leader serving asa post-market vigilance (reportable event) and surveillance subject matter expert and representativetoimprove awareness, visibility, and communication onquality/compliance initiativessupporting post-market vigilance. Thisrole will providedirectiontoindividuals whoare responsible forthe assessment, follow-up, coding,andvigilance activities for complaints determined to bereportablefor the US FDA and other countries.The role requires strongorganizationskillsandattention to detail while working in cross functional teams toaccomplishdepartmental and company goals. 

Key Responsibilities:

• Manage,mentor,providedirectionto,and developdirect reportsthroughreviews, meetings, and daily interactionsto ensure thetimelyprocessing of customer complaints andadverse event reportsin aface-paced work environment.

• Provide coaching and feedbackin accordance withcompany 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 communicationregardinggoals andobjectives.

• Provide input to management to define reports/dashboards toidentifydelinquency or backlog in all aspects of thevigilanceprocess.

• Collaborate withengineering, 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/orapprove vigilance reports to ensure on time submissions to theappropriate regulatoryauthorities, 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 complianceensuring itoccurs per procedures, standards, and regulations.

• Support and/or leaddepartmental non-conformances, events,andCAPAs.

• 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 initiativesor special projects, as assigned, with minimal supervision. 

• Perform other duties as.

Qualifications: 

• Bachelor’s degree anddemonstrated5+ years’experiencein medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support orappropriate combinationof relevant education and experience preferred.

Preferred Skills and Competencies:

• Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality andtimelywork.

• 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 anddemonstratedknowledge 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.

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

• Strong emphasis and understanding of a formalized medicaldeviceQuality Management Systemand regulatory framework. 

• Ability to generate, verify, andmaintainaccuraterecords.

• Must have analytical skills, be detail oriented, and have good interpersonal skills.

• Strongproficiencyin common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.

Physical Requirements:

• General office environment – may sit forlong periodsof time.

• This position requires extensive computer use.