Manager, Post Market Compliance – Global Product Monitoring
Diabetes Youth Families
full-time
Posted on:
Location Type: Hybrid
Location: Acton • Massachusetts • United States
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Salary
💰 $112,300 - $168,400 per year
About the role
- Develops and maintains product knowledge of existing and new products
- Engages globally with internal stakeholders, developing and maintaining strong relationships to ensure effective processes while identifying improvements to drive efficiency and compliance
- Represents GPM at cross-functional, multi-level, and external meetings
- Adheres to all regulatory compliance and quality standards
- Maintains awareness of new or revised regulations, standards, and/or guidelines
- Reviews, evaluates and approves document changes
- Ensures required documentation, records, and reports are complete, accurate, and properly maintained
- Ensures key performance indicators are met or exceeded
- Works collaboratively with the French local contact for vigilance (matériovigilance)
Requirements
- BS/BA degree with 8+ years’ work experience
- At least 4 years’ experience in post-market surveillance or post-market vigilance in the MedTech industry
- Strong working knowledge of global medical device regulations and standards, including 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485 & 14971, EU MDR, CMDR, and other global regulations, standards, and guidelines (such as MDSAP, IMDRF, MDCG, MEDDEV)
- Experience influencing without authority and facilitating cross-functional collaboration
- Experience managing cross-functional task- or project-focused teams on a global basis across different locations and cultures
- Proven experience responding to regulatory authority inquiries
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
post-market surveillancepost-market vigilanceglobal medical device regulations21 CFR 82021 CFR 80321 CFR 806ISO 13485ISO 14971EU MDRCMDR
Soft Skills
relationship buildingcross-functional collaborationinfluencing without authorityfacilitating teamworkcommunicationproblem-solvingorganizational skillsattention to detailadaptabilityleadership