Need a candidate with a minimum of 5 years of post-market surveillance experience within the medical device industry.
5-8+ years of medical device complaint handling or post-market surveillance experience.
Strong working knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, and medical device quality systems.
Demonstrated experience independently evaluating, investigating, documenting, and closing complex medical device complaints.
Experience supporting adverse event reporting, complaint investigations, CAPA activities, complaint trending, risk assessments, and regulatory decision making.
Advanced proficiency with Microsoft Excel (pivot tables, advanced formulas, Power Query, data modeling, and data analysis techniques) and experience using SQL, databases, Salesforce, complaint handling systems, eQMS, and business intelligence/reporting tools.