Post-Market Surveillance Specialist

DEPARTMENT: Quality

JOB DESCRIPTION: Post-Market Surveillance Specialist

PURPOSE: The Post-Market Surveillance Specialist ensures compliance with US medical device regulations through the systematic handling, analysis, and reporting of product complaints, vigilance cases, and post-market data. This role supports patient safety, regulatory compliance, and product improvement by liaising between field specialists, healthcare professionals, and internal quality and regulatory teams.

GENERAL RESPONSIBILITIES:

• Assist in day-to-day complaint processing including recording, monitoring, and tracking product complaints.
• Participate in vigilance activities, including the assessment of reportable events and the preparation and timely submission of Medical Device Reports (MDRs) to the FDA.
• Ensure complaints are investigated, closed and documented per applicable company procedures.
• Maintain accurate and up-to-date documentation of investigations, including complaint files, investigation reports, and FDA submissions.
• Collect, evaluate, and analyze investigation data to identify trends, potential risks, and opportunities for product improvement.
• Monitor and report key performance indicators (KPIs) for PMS activities.
• Participate in recall activities including investigation, risk assessment, communication with relevant stakeholders, and coordination of corrective actions.
• Communicate professionally and with a customer-focused approach with external stakeholders.
• Participate in QMS processes, including but not limited to audits, corrective and preventative action (CAPA) investigations, and document control.
• Prepare and update Quality documents such as SOPs, Work Instructions and Forms.
• Work closely with QA, Regulatory Affairs, R&D and Clinical Specialists to assess failure modes.

SKILL AND EDUCATION REQUIREMENTS:

• Bachelor of Science in Engineering or related field, or equivalent combination of experience and training.
• 5 years’ experience in Complaint Handling, Post-Market Surveillance, or related position.
• Medical device industry experience required.
• Strong knowledge of applicable U.S. medical device regulations.
• Experienced in using E-Submitter for regulatory submissions and comfortable with Microsoft Office tools for documentation, data analysis, and reporting.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person