Post Market Surveillance Analyst Job at Avanos (Alpharetta)

Job Description

The Post Market Specialist – Data Analyst supports post-market surveillance (PMS) activities by collecting, compiling, and analyzing data to ensure regulatory compliance. This role contributes to the development of Periodic Safety Update Reports (PSURs), PMS reports, and other regulatory submissions, and supports the preparation of post-market surveillance trend reports, including limited analysis of emerging trends. The position also supports the management of recall documentation and assists with the investigation and documentation of low-risk customer complaints.

Job Responsibility

Compile, analyze, and trend post-market data from multiple sources (e.g., complaints, adverse events, vigilance reports, literature, and regulatory databases)
Support the preparation of PMS reports, PSURs, and other regulatory-required documentation in accordance with global regulations (e.g., EU MDR, FDA, Health Canada)
Support the identification and analysis of emerging trends related to product safety, field actions, recalls, and regulatory enforcement (e.g., warning letters, recalls, safety alerts)
Perform statistical and qualitative analyses to detect safety signals and support risk management activities
Assist in the development and maintenance of dashboards and reporting tools for ongoing monitoring of product performance
Support recall and field action activities, including data collection, impact assessment, and reporting
Ensure data integrity, accuracy, and compliance with internal procedures and regulatory requirements
Assists with the investigation and documentation of low-risk customer complaints
Support audits and inspections by providing relevant data and documentation

Requirements

Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Statistics, Data Analytics, or related discipline)
2–5 years of experience in medical device, pharmaceutical, or regulated industry (preferred)
Experience with post-market surveillance, complaint handling, or regulatory reporting is highly desirable
Strong data analysis skills (e.g., Excel, statistical tools, or data visualization platforms such as Power BI, Tableau)
Ability to work at least three days per week (Tuesday – Thursday) in the office located in Alpharetta

Nice to have

Familiarity with global regulatory requirements (e.g., EU MDR, FDA, Health Canada) preferred
Knowledge of risk management principles (ISO 14971) is a plus

What we offer

401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria
HQ region voted 'best place to live' by USA Today
uncapped sales commissions

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Post Market Surveillance Analyst

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