What are the responsibilities and job description for the Senior Post Market Surveillance Specialist position at NIPRO Corporation - Global?
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:
- Complaint handling & investigations
- FDA MDR & Health Canada MPR reporting
- Post‑market data trending & risk assessment
- Cross‑functional collaboration & audit support
- 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 (<10%) with overnight stay may be required.
Education
- High school diploma or GED required, college degree preferred.
- Experience in a medical device or pharmaceutical Quality environment preferred.