Global Post-Market Surveillance Lead

Avanos Medical, Inc.; Alpharetta (GA); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

401(k) match

Free onsite gym

Onsite cafeteria

HQ region best place to live

Résumé du poste

Avanos Medical, Inc. seeks a Senior Post-Market Surveillance Analyst in Alpharetta, GA. You will lead global post-market surveillance activities, coordinate regulatory reporting, and drive data-driven improvements in complaint handling across regions including FDA, EU MDR, and Health Canada.

This role requires strong regulatory knowledge, extensive experience with complaint systems, and collaboration with Clinical, Quality, and Manufacturing teams to ensure timely actions and robust metrics.

Qualifications

• B.S./B.A. in a related field required.
• 7+ years in healthcare/medical device or equivalent MS/MA or RN.
• Experience with complaint handling systems.
• Fundamental knowledge of ISO, FDA, cGMP, EU MDR, MDSAP, EUDAMED and Health Canada.

Responsabilités

• Oversee global post-market surveillance reporting to authorities.
• Coordinate with regulatory teams on on-time reporting (FDA, EU MDR, Health Canada).
• Lead data analysis and trend reporting for complaints and CAPAs.
• Provide training on post-market surveillance systems and processes.
• Collaborate with cross-functional teams and regional partners.

Connaissances

Strong oral and written communication

Analytical skills

Organizational skills

Regulatory knowledge

Formation

B.S. or B.A. in a related field

7+ years in Healthcare/Medical Device industry or MS/MA or RN

Outils

EtQ Reliance

Description du poste

Avanos Medical, Inc. seeks a Senior Post-Market Surveillance Analyst in Alpharetta, GA. You will lead global post-market surveillance activities, coordinate regulatory reporting, and drive data-driven improvements in complaint handling across regions including FDA, EU MDR, and Health Canada.

This role requires strong regulatory knowledge, extensive experience with complaint systems, and collaboration with Clinical, Quality, and Manufacturing teams to ensure timely actions and robust metrics.