Manager, Global Vigilance Writing

Diabetes Youth Families

Manager leading post-market vigilance writing in a medical device company. Focusing on quality compliance initiatives and team direction.

Posted 6/4/2026full-timeActon • Massachusetts • 🇺🇸 United StatesSeniorLead💰 $112,300 - $168,400 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

complaint resolutionKey Performance Indicators (KPIs)root cause analysisline balancingvalue stream mappingpareto analysismedical device complaint processesregulatory compliancequality managementtechnical writing

Soft Skills

leadershipmentoringcoachingteam developmentcommunicationorganizational skillsproblem-solvingperformance managementtrainingsupervision

Tools & Technologies

MS Officeword processingspreadsheet softwarecomplaint lab systemsbiohazardous materials handling

Industry Keywords

FDA regulationscontinuous improvementcustomer satisfactiontechnical feedbackdepartmental requirements

About the role

Key responsibilities & impact

Monitor complaint lab activity to ensure timely complaint resolution that meets or exceeds departmental, customer and regulatory requirements.
Approve / Sign-off work evaluations from complaint lab team.
Technical expert responsible for providing feedback and training concerning write-ups and approvals to drive team improvement.
Utilize superior leadership to model, reward, and enforce behaviors that support Insulet’s culture.
Supervise, mentor, and provide work direction to the complaint lab team.
Drive performance and establish Key Performance Indicators (KPIs) to achieve organizational goals for complaint rate, daily throughput, and efficient staff utilization.
Works closely with appropriate personnel in R&D, Operations, and Quality Assurance to further analyze investigation results to determine root cause to mitigate and/or eliminate future complaints or customer dissatisfaction.
Promote and instill a culture of continuous improvement through standard improvement principles and practices (i.e. line balancing, value stream mapping, pareto analysis, etc.).
Establish work planning to include development and maintenance of a plan incorporating hiring, training, efficiencies, etc.
Must adhere to all regulatory requirements for complaint handling including the FDA and any other competent authority as required.
Effectively write responses to competent authorities upon their request for more information.
Purchase appropriate consumables for the continued operation of the complaint Lab.
Direct the training efforts on evaluations and procedural changes.
Performs other duties as assigned.

Requirements

What you’ll need

BS/BA degree in engineering
Demonstrated people management experience leading teams of 5 or more technical employees
Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work
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
Ability to organize and follow through with tasks with minimal supervision
MS Office, strong word processing and spreadsheet skills
Familiarity with the handling of biohazardous materials.

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs