Post Market Surveillance Specialist, Contract (Medical Devices)

Location: Billerica, Massachusetts, United States; onsite office work

Company

hirify.global develops in vitro diagnostic instrumentation and biotechnology solutions for biopharmaceutical and clinical markets, with FDA-registered and ISO-certified manufacturing operations.

What you will do

• Compile, analyze, and report post-production information within the post-market surveillance system.
• Lead ongoing post-market surveillance meetings for multiple product families.
• Maintain complaint-handling systems, metrics, policies, procedures, and compliance programs.
• Monitor KPIs, perform risk assessments, and evaluate process effectiveness.
• Report issues to management to support timely resolution of customer complaints.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, Engineering, Quality, Purchasing, and Technical Support.

Requirements

• Bachelor’s degree in a scientific or technical discipline.
• At least three years of experience in the medical device or diagnostic industry.
• At least two years of experience in post-market surveillance, complaint handling, customer support, or quality assurance in a medical device or diagnostic environment.
• Experience submitting Medical Device Reports or adverse-event reports to regulatory agencies.
• Experience writing corporate Standard Operating Procedures in a GMP environment and working in FDA-regulated or other regulated environments.
• Ability to perform data analysis on post-market, quality assurance, or quality-system data.

Nice to have

• Experience with post-market surveillance under IVDR regulations.
• Knowledge of auditing, statistics, and database management.

Culture & Benefits

• Collaborative, empowered culture guided by customer centricity, ingenuity, ownership, accountability, collaboration, and integrity.
• Mission-driven work supporting patient care, drug development, and global health.
• Work includes computer use for extended periods, phone, video, and written communication.
• Ability to lift and carry up to 25–50 pounds and move around the office as needed.