Post Market Surveillance Analyst

Job Summary

The Post Market Surveillance (PMS) Analyst is responsible for supporting domestic and international post-market surveillance activities for medical devices manufactured, marketed, distributed, and serviced by ZOLL. This role supports complaint handling, regulatory reporting, and surveillance processes to ensure compliance with applicable global regulations and quality system requirements, including FDA Quality System Regulations, MDR, MDSAP, ISO 13485, and other international requirements. The PMS Analyst collaborates closely with Quality Assurance, Regulatory Affairs, Technical Support, Service, Compliance, Engineering, and Customer-facing teams to evaluate complaints, maintain complaint records, support regulatory reporting activities, and contribute to continuous improvement initiatives within the Post Market Surveillance program.

Essential Functions

• Review, assess, and process customer complaints in accordance with internal procedures and regulatory requirements.
• Perform preliminary complaint evaluations and escalate potential reportable events for further review.
• Coordinate complaint investigations and ensure complaint records are complete, accurate, and closed in a timely manner.
• Maintain complaint documentation and records to support regulatory compliance and audit readiness.
• Support the preparation and submission of reportable event documentation to regulatory authorities within required timelines.
• Evaluate complaint information for completeness and conduct follow-up activities to obtain additional information when needed.
• Communicate with customers and internal stakeholders to gather information necessary for complaint assessment and investigation.
• Support product investigations, including returned product evaluations and coordination with engineering and technical teams.
• Assist in identifying complaint trends, emerging product issues, and potential safety concerns, escalating findings as appropriate.
• Support Post Market Surveillance reporting, metrics, and continuous improvement initiatives.
• Participate in special projects related to complaint handling, regulatory reporting, and post-market surveillance processes.
• Maintain storage, retrieval, and organization of active and inactive complaint records.
• Promote compliance with applicable regulations, quality standards, and company procedures.

Required/Preferred Education and Experience

• Bachelor's degree in Science, Engineering, Healthcare, Regulatory Affairs, Quality, or a related discipline required.
• 2-5 years of experience in complaint handling, post-market surveillance, quality, regulatory affairs, or a related function in a regulated industry.
• Medical device, healthcare, or life sciences industry experience required.
• Exposure to complaint management systems and quality management systems required.

Knowledge, Skills and Abilities

• Working knowledge of medical device regulations and quality system requirements, including FDA QSR, 21 CFR Part 803, EU MDR, ISO 13485, and MDSAP preferred.
• Strong analytical and problem-solving skills with the ability to evaluate technical information and identify potential compliance concerns.
• Excellent written and verbal communication skills.
• Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
• Ability to work independently while effectively collaborating across functional teams.
• Strong organizational and time management skills.
• Proficiency with Microsoft Office applications and complaint management systems.
• Ability to interpret procedures, technical documentation, and regulatory requirements.
• Demonstrated commitment to quality, compliance, and continuous improvement.