Senior Post-Market Surveillance Specialist

Job overview

The Senior Post-Market Surveillance Specialist role is onsite in Burnsville, MN. The stated annual base salary range is $110,000–$132,000. The specialist reports to the Director of Quality and supports post-market surveillance activities for Imricor Medical Systems. The role helps ensure medical-device complaints are investigated, analyzed, and reported within applicable regulatory timeframes. It works closely with Regulatory and Engineering teams to maintain complaint records, identify trends, support inspections, and prepare surveillance plans and safety reports.

What you'll do

• Support timely global medical-device reporting
• train other groups on complaint reporting
• perform and present trend analyses
• process complaints and maintain the database
• lead product complaint investigations
• support regulatory inspections
• determine appropriate testing of returned products
• conduct customer and field investigations
• author surveillance plans, reports, and periodic safety update reports.

What we're looking for

Skills & competencies

senior post-market surveillance specialist

burnsville mn

imricor medical systems

medical devices

post-market surveillance

complaint investigations

regulatory reporting

quality systems

fda 21 cfr

european mdr

iso 14971

iso 13485

$110k–$132k/year

travel under 10%

Work arrangement

• Weekend coverage required

Benefits & perks

• May be eligible for medical, dental, and vision coverage
• health savings accounts
• flexible spending accounts
• disability benefits
• life insurance
• and retirement benefits.

Why this role

Requires knowledge of global medical-device reporting regulations, including European MDR, FDA 21 CFR, Australian TGA, ISO 14971, and ISO 13485.

About the employer

Imricor Medical Systems Inc is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.