Post Market Surveillance Analyst (Medical Devices)

Location: Chelmsford, Massachusetts, United States

Annual salary: $69,900–$87,300

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions. Products support EMS, hospitals, public safety, and military customers worldwide.

What you will do

• Review, assess, process, and document customer complaints in accordance with internal procedures and regulatory requirements.
• Perform preliminary evaluations, identify potentially reportable events, and escalate cases for further review.
• Coordinate complaint investigations, returned product evaluations, and follow-up activities with engineering and technical teams.
• Prepare and support reportable event submissions to regulatory authorities within required timelines.
• Identify complaint trends, emerging product issues, and potential safety concerns.
• Maintain complaint records, surveillance metrics, audit-ready documentation, 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 regulated-industry function.
• Experience in the medical device, healthcare, or life sciences industry.
• Experience with complaint management systems and quality management systems.
• Working knowledge of FDA Quality System Regulations, 21 CFR Part 803, EU MDR, ISO 13485, and MDSAP.
• Strong analytical, communication, organizational, problem-solving, and prioritization skills.

Culture & Benefits

• Work in a fast-growing organization operating in more than 140 countries.
• Collaborate across Quality Assurance, Regulatory Affairs, Technical Support, Service, Compliance, Engineering, and customer-facing teams.
• Contribute to products intended to improve outcomes for patients with critical cardiopulmonary conditions.
• Comprehensive benefits plans are available.

Hiring process

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