Post Market Surveillance Analyst (Medical Devices)

Location: On-site in Chelmsford, Massachusetts; applicants must reside within a reasonable commuting distance. Relocation is not offered.

Annual salary: $69,900–$87,300.

Company

hirify.global develops medical devices, software, and related services for serious cardiopulmonary and respiratory conditions, serving EMS, hospital, public safety, and military customers worldwide.

What you will do

• Review, assess, process, and document domestic and international customer complaints.
• Perform preliminary evaluations and escalate potentially reportable events.
• Coordinate complaint investigations, returned-product evaluations, follow-ups, and timely record closure.
• Support preparation and submission of reportable-event documentation to regulatory authorities.
• Identify complaint trends, emerging product issues, and potential safety concerns.
• Maintain surveillance metrics and records while supporting compliance, audit readiness, and continuous improvement initiatives.

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.
• Required experience in the medical device, healthcare, or life sciences industry.
• Required exposure to complaint management systems and quality management systems.
• Working knowledge of medical device regulations and quality requirements, including FDA QSR, 21 CFR Part 803, EU MDR, ISO 13485, and MDSAP.
• Strong analytical, problem-solving, communication, organizational, and time-management skills, with attention to detail and the ability to manage multiple priorities.
• Ability to work independently, collaborate across Quality Assurance, Regulatory Affairs, Technical Support, Service, Compliance, Engineering, and customer-facing teams, and interpret procedures, technical documentation, and regulatory requirements.
• Proficiency with Microsoft Office applications and complaint management systems.
• Demonstrated commitment to quality, compliance, and continuous improvement.

Culture & Benefits

• Full-time, on-site work supporting products intended to improve outcomes for patients with critical cardiopulmonary conditions.
• Culture emphasizes innovation, self-motivation, an entrepreneurial spirit, and commitment to patient impact.
• Comprehensive benefits are available.
• ZOLL does not provide immigration-related sponsorship; applicants must not require sponsorship now or in the future, including H1B, TN, STEM, or OPT sponsorship.
• Physical demands include constant sitting, frequent repetitive motions, and occasional standing, walking, talking, and hearing.

Hiring process

• Applications are accepted on an ongoing basis until the position is filled.