Clinical Specialist, Post Market Surveillance

Abbott seeks a Clinical Specialist for Post Market Surveillance in Burlington, Massachusetts, to serve as a clinical subject matter expert managing medical device reports, regulatory investigations, and complaint documentation. The role involves directing MDR submissions, supporting regulatory inspections, and collaborating across departments on product safety matters.

Responsibilities

• Manage MDR submission documentation, follow-up, and interaction with complaint analysts and investigators
• Ensure global medical device reports are filed within regulatory timeframes
• Represent Product Surveillance at cross-functional meetings and regulatory agency inspections
• Train new employees on complaint handling and conduct training for other departments on reporting procedures
• Conduct independent investigations with customers and field staff on product complaints

Requirements

• Four-year degree in clinical, medical, scientific, or healthcare field (or two-year degree with relevant experience)
• Minimum three years of professional experience
• Strong verbal and written communication skills across organizational levels
• Proficient computer skills
• Critical thinking with attention to detail and problem-solving ability
• Ability to multitask, prioritize, and meet deadlines in fast-paced environment
• Knowledge of global regulations for medical device reporting and complaint handling (preferred)

Compensation: $78,000–$156,000 base