MDR Specialist (Medical Devices)

Location: Remote

Salary: $75,000–$85,000 annually

Company

hirify.global provides services to the life sciences industry to support the development, manufacture, and distribution of healthcare products in compliance with regulatory requirements.

What you will do

• Review and assess medical device product complaints according to company procedures and regulatory requirements.
• Evaluate complaint events for reportability and potential patient safety impact.
• Prepare and submit Medical Device Reports and related regulatory documentation.
• Conduct or support complaint investigations, documentation, and timely record closure.
• Collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, and Clinical teams.
• Support post-market surveillance, complaint trending, eQMS records, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in a scientific, engineering, healthcare, or related discipline, or equivalent experience.
• 5+ years of experience in medical device complaint handling, vigilance, post-market surveillance, or quality assurance.
• Experience authoring and submitting Medical Device Reports and assessing regulatory reportability.
• Knowledge of FDA medical device regulations, including 21 CFR Part 803 and 21 CFR Part 820, and ISO 13485.
• Experience with complaint investigations, risk-based decision-making, eQMS, and complaint management tools.
• Strong technical writing, communication, analytical skills, and ability to work independently in a regulated environment.

Nice to have

• Experience supporting Class II or Class III medical devices.
• Experience in post-market surveillance, complaint trending, or device vigilance programs.
• Working knowledge of risk management and adverse event reporting processes.

Culture & Benefits

• Full-time remote contract position lasting 3–6 months, with potential extension.
• W2 temporary employment.
• Medical and sick time benefits.
• Coaching, professional development, and learning support.