Manager, Post Market Compliance – Global Product Monitoring

Role Overview

• 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