Post-Market Surveillance Specialist

Job overview

The Post-Market Surveillance Specialist role is onsite for one week of training in Billerica, MA; the posting also says the role can sit in Billerica, Waltham, or Norwood, MA, or Westbrook, ME. Compensation is not specified. The specialist supports post-market surveillance and complaint-handling compliance at Nova Biomedical, a diagnostics and in-vitro diagnostic instrumentation company focused on advancing patient care and scientific discovery. The specialist compiles and analyzes post-production information, leads product-family surveillance meetings, and supports complaint systems, policies, and metrics. This work helps the company assess product experience and maintain compliance with applicable worldwide regulations and quality requirements.

What you'll do

• Compile, analyze, and report post-production information
• lead post-market surveillance meetings for product families
• assist with policies and procedures
• monitor KPIs and conduct risk assessments
• report issues to management to support complaint resolution
• mentor team members on complaint handling and regulatory compliance
• support complaint systems and post-market compliance programs
• collaborate with regulatory, research and development, manufacturing, engineering, quality, purchasing, and technical support teams.

What we're looking for

Skills & competencies

post-market surveillance

norwood ma

nova biomedical

medical devices

diagnostics

complaint handling

regulatory compliance

quality assurance

kpi monitoring

risk assessment

billerica training

multiple work locations

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in a scientific or technical discipline, three years in medical device or diagnostics, and two years in post-market surveillance, complaint handling, customer support, or quality assurance. Medical device reporting/adverse-event reporting and regulated-environment experience are specified; IVDR experience and auditing, statistics, and database knowledge are preferred.

About the employer

Nova Biomedical is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.