Senior Post Market Surveillance Specialist
NIPRO Corporation - Global, Greenville, NC, United States
Nipro is hiring a
Senior
Post‑Market Surveillance Specialist
to lead complaint handling and adverse event reporting across the U.S. and Canada. This role ensures compliance with FDA and Health Canada regulations while driving trend analysis and risk management to support patient safety.
Key Focus
Assist global business partners with the creation, review, escalation, and monitoring of complaints
Collaborate cross-functionally with Quality, Regulatory, Technical Service Engineering, and Clinical teams to ensure effective resolution of product issues
Provide monthly analysis and trending of post‑market data to identify potential risks
Escalate safety or performance issues to the Post Market Surveillance Manager
Support audits and inspections as a Subject Matter Expert (SME) and ensure records are audit‑ready at all times
Requirements
5+ years in medical device PMS or complaint handling
Strong FDA (21 CFR 803/820) & Health Canada knowledge
Familiarity with ISO 13485 / 14971 and eQMS tools
Strong analytical and communication skills
Familiarity with MasterControl software platform is a plus
Excellent computer proficiency (MS Office – Word, Excel, and Outlook)
Strong communication and cross‑cultural collaboration skills
Sense of urgency with the ability to prioritize tasks
Physical Requirements
Ability to consistently perform the essential job functions safely and successfully with the ADA, FMLA and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.
Mostly sedentary positions that require prolonged sitting, generally in an office environment.
Minimal travel (
Education
High school diploma or GED required, college degree preferred.
Experience in a medical device or pharmaceutical Quality environment preferred.
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Senior
Post‑Market Surveillance Specialist
to lead complaint handling and adverse event reporting across the U.S. and Canada. This role ensures compliance with FDA and Health Canada regulations while driving trend analysis and risk management to support patient safety.
Key Focus
Assist global business partners with the creation, review, escalation, and monitoring of complaints
Collaborate cross-functionally with Quality, Regulatory, Technical Service Engineering, and Clinical teams to ensure effective resolution of product issues
Provide monthly analysis and trending of post‑market data to identify potential risks
Escalate safety or performance issues to the Post Market Surveillance Manager
Support audits and inspections as a Subject Matter Expert (SME) and ensure records are audit‑ready at all times
Requirements
5+ years in medical device PMS or complaint handling
Strong FDA (21 CFR 803/820) & Health Canada knowledge
Familiarity with ISO 13485 / 14971 and eQMS tools
Strong analytical and communication skills
Familiarity with MasterControl software platform is a plus
Excellent computer proficiency (MS Office – Word, Excel, and Outlook)
Strong communication and cross‑cultural collaboration skills
Sense of urgency with the ability to prioritize tasks
Physical Requirements
Ability to consistently perform the essential job functions safely and successfully with the ADA, FMLA and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.
Mostly sedentary positions that require prolonged sitting, generally in an office environment.
Minimal travel (
Education
High school diploma or GED required, college degree preferred.
Experience in a medical device or pharmaceutical Quality environment preferred.
#J-18808-Ljbffr