Post Market Surveillance Analyst

ZOLL Medical Corporation • Chelmsford, MA

18h • $69,900 - $87,300 • Onsite

About The Position

The Post Market Surveillance (PMS) Analyst supports domestic and international post-market surveillance activities for medical devices manufactured, marketed, distributed, and serviced by ZOLL. The 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 analyst collaborates with Quality Assurance, Regulatory Affairs, Technical Support, Service, Compliance, Engineering, and customer-facing teams to evaluate complaints, maintain complaint records, support regulatory reporting, and contribute to continuous improvement initiatives within the Post Market Surveillance program. The position is on-site in Chelmsford, Massachusetts, and applicants are expected to live within a reasonable commuting distance. Relocation is not offered, and ZOLL does not provide immigration-related sponsorship for this role.

Requirements

• Bachelor's degree in Science, Engineering, Healthcare, Regulatory Affairs, Quality, or a related discipline.
• 2–5 years of experience in complaint handling, post-market surveillance, quality, regulatory affairs, or a related function in a regulated industry.
• Experience in the medical device, healthcare, or life sciences industry.
• Exposure to complaint management systems and quality management systems.
• Strong analytical and problem-solving skills, including 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 and collaborate effectively 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.
• Commitment to quality, compliance, and continuous improvement.

Nice To Haves

• Working knowledge of medical device regulations and quality system requirements, including FDA QSR, 21 CFR Part 803, EU MDR, ISO 13485, and MDSAP.

Responsibilities

• 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 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 needed for complaint assessment and investigation.
• Support product investigations, including returned product evaluations and coordination with engineering and technical teams.
• Help identify 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level