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, serving EMS, hospital, public safety, and military customers worldwide.

What you will do

• Review, assess, process, and document customer complaints in accordance with internal procedures and applicable regulations.
• Perform preliminary evaluations, escalate potentially reportable events, and support regulatory submissions within required timelines.
• Coordinate complaint investigations, returned-product evaluations, follow-up activities, and timely record closure.
• Collaborate with Quality Assurance, Regulatory Affairs, Technical Support, Service, Compliance, Engineering, and customer-facing teams.
• Identify complaint trends, emerging product issues, and potential safety concerns, and support post-market surveillance metrics and continuous improvement.
• Maintain organized active and inactive complaint records to support regulatory compliance and audit readiness.

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.
• Medical device, healthcare, or life sciences industry experience and exposure to complaint management and quality management systems.
• Working knowledge of FDA Quality System Regulations, 21 CFR Part 803, EU MDR, ISO 13485, and MDSAP.
• Strong analytical, problem-solving, communication, organizational, and time-management skills, with the ability to work independently and collaborate across functions.
• Proficiency with Microsoft Office, complaint management systems, technical documentation, procedures, and regulatory requirements.

Culture & Benefits

• Work in a fast-growing medical technology company operating in more than 140 countries.
• Contribute to products and services intended to improve outcomes for patients with critical cardiopulmonary conditions.
• Company culture values innovation, self-motivation, an entrepreneurial spirit, quality, compliance, and continuous improvement.
• Comprehensive benefits plans are available.