Global Post-Market Surveillance Lead Analyst

Avanos Medical; Alpharetta (GA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Benefits on day 1

Free onsite gym

Onsite cafeteria

HQ region voted 'best place to live'

Uncapped sales commissions

Job summary

Avanos Medical, headquartered in Alpharetta, GA, seeks a Senior Post-Market Surveillance Analyst to lead global health authority reporting for domestic and international regions. You will manage complaint intake decisions, perform data-driven trend analyses, and drive timely regulatory submissions across FDA, EU MDR, and Health Canada.

You will collaborate with CHU and cross-functional teams to ensure robust investigations, CAPA, and continuous improvement of surveillance processes.

Qualifications

• B.S. or B.A. in a related field.
• 7+ years in Healthcare, Medical Device, Pharmaceutical industry or equivalent; M.S./M.A. or RN acceptable.
• Experience with complaint handling systems.
• Fundamental knowledge of ISO, FDA, cGMP, EU MDR, MDSAP, EUDAMED, Health Canada regulations.

Responsibilities

• Monitor reportability decisions for global regulatory agencies including FDA, EU MDR, and Canada.
• Review reportable events and decide whether to report to global agencies with clinical input.
• Prepare and submit reports (FDA Medwatch, Health Canada MDR, etc.) within required timelines.
• Collaborate with Complaint Handling Unit to ensure reporting accuracy.
• Perform tracking and trending of potentially reportable events.
• Provide training on post-market surveillance systems and processes.

Skills

Strong communication

Analytical skills

Organizational skills

Microsoft Office

Education

B.S./B.A. in related field

M.S./M.A. in related field or RN

Job description

Avanos Medical, headquartered in Alpharetta, GA, seeks a Senior Post-Market Surveillance Analyst to lead global health authority reporting for domestic and international regions. You will manage complaint intake decisions, perform data-driven trend analyses, and drive timely regulatory submissions across FDA, EU MDR, and Health Canada.

You will collaborate with CHU and cross-functional teams to ensure robust investigations, CAPA, and continuous improvement of surveillance processes.