Clinical Specialist: Post-Market Surveillance & MDR Expert

Thornton Tomasetti; Burlington (MA); Hybrid; USD 78,000 - 156,000; Full time

Job summary

Abbott Laboratories in Burlington, MA seeks a Clinical Specialist for Post Market Surveillance to act as a clinical subject matter expert within the Product Surveillance Department. You will guide complaint investigations, ensure timely medical device reporting, and collaborate across teams to meet regulatory standards.

This role requires a four-year degree in a clinical/medical field (or equivalent experience), strong communication, and the ability to work independently and in a team in a

Qualifications

• Four-year degree in clinical, medical, scientific or healthcare fields or 2-year degree with relevant experience.
• Strong communications at multiple organizational levels.
• Ability to follow regulatory requirements and maintain documentation.

Responsibilities

• Assist in filing global medical device reports within regulatory timeframes.
• Represent Product Surveillance at cross-functional meetings as needed.
• Train new staff on complaint handling and reporting requirements.
• Support inspections by regulatory agencies and investigations with field staff.
• Ensure accuracy and completeness of complaint information and records.

Skills

Verbal and written communication

Critical thinking

Team collaboration

Proficient computer skills

Organization and multitasking

Education

Bachelor's degree in clinical/medical/healthcare fields

Tools

MS Office

Job description

Abbott Laboratories in Burlington, MA seeks a Clinical Specialist for Post Market Surveillance to act as a clinical subject matter expert within the Product Surveillance Department. You will guide complaint investigations, ensure timely medical device reporting, and collaborate across teams to meet regulatory standards.

This role requires a four-year degree in a clinical/medical field (or equivalent experience), strong communication, and the ability to work independently and in a team in a