Tax consultant focusing on compliance and team leadership at nbs partners in Hamburg. Engaging in strategic tax developments and client consultations.
DF
Hybrid Manager, Post Market Compliance – Global Product Monitoring
Posted 15 hours ago
About the role
- Manager of Post Market Compliance overseeing post-market surveillance for global medical device regulations. Engaging with cross-functional teams and maintaining compliance standards in a hybrid role.
Responsibilities
- 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
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