Global Post-Market Surveillance Clinical Specialist

Abbott; Burlington (MA); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott Laboratories is seeking a Clinical Specialist, Post Market Surveillance to serve as a clinical SME for the Product Surveillance Department. You will handle medical device report documentation and follow-up, guiding complaint reporting and ensuring records are complete.

The role involves filing global MDRs timely, training staff on complaint handling, supporting regulatory inspections, and collaborating with multiple teams to investigate product complaints.

Qualifications

• Four-year degree preferred in clinical, medical, scientific or healthcare fields or 2-year degree with relevant experience.
• Strong verbal and written communication abilities across organization levels.
• Critical thinking and problem solving with attention to detail.
• Proficient computer skills required.
• Ability to work in a team and as an individual contributor in a fast-paced environment.
• Ability to multitask, prioritize and meet deadlines.
• Knowledge of global regulations for medical device reporting and complaint handling is preferred.

Responsibilities

• Assist in ensuring all global medical device reports are filed within regulatory timeframes.
• Represent Product Surveillance at cross-functional meetings as requested.
• Provide training on complaint reporting and maintain training documents.
• Maintain accurate complaint information.
• Support inspections by regulatory agencies (e.g., FDA, TUV) as required.
• Collaborate with team members and other departments needing product complaint information.
• Act as a clinical subject matter expert to Product Surveillance team members.
• Assist with investigations with customers or field staff with minimal direction.

Skills

Verbal & written communication

Critical thinking

Teamwork & independent work

Attention to detail

Proficient computer skills

Multitasking

Education

Four-year degree

Two-year degree with relevant experience

Job description

Abbott Laboratories is seeking a Clinical Specialist, Post Market Surveillance to serve as a clinical SME for the Product Surveillance Department. You will handle medical device report documentation and follow-up, guiding complaint reporting and ensuring records are complete.

The role involves filing global MDRs timely, training staff on complaint handling, supporting regulatory inspections, and collaborating with multiple teams to investigate product complaints.