Post Market Surveillance Specialist, Contract

Nova Biomedical • Waltham, MA

5d

About The Position

The Post Market Surveillance (PMS) Specialist prepares Post-Market Surveillance reports, conducts PMS meetings, and supports the Post Market department in maintaining complaint handling systems, metrics, policies, and procedures to ensure compliance with applicable worldwide regulations and requirements. The role works with cross-functional teams to collect, analyze, and report post-production information while supporting quality and regulatory compliance initiatives.

The position may be based in Billerica, Waltham, Norwood, Massachusetts, or Westbrook, Maine. The employee must complete one week of onsite training in Billerica. The posting also lists Billerica, Massachusetts as the work location.

Requirements

• Bachelor’s degree in a scientific or technical discipline.
• At least three years of experience within the medical device or diagnostic industry.
• At least two years of post-market surveillance, complaint handling, customer support, and/or quality assurance experience within a medical device or diagnostic environment.
• Experience submitting Medical Device Reports (MDRs) and/or adverse event reports to regulatory agencies.
• Experience writing corporate-level Standard Operating Procedures (SOPs) within a GMP environment.
• Experience performing data analysis on post-market, quality assurance, or other quality system data.
• Medical diagnostic or medical device experience.
• Experience working within FDA-regulated or other regulated environments.
• Comfort working at a computer for extended periods.
• Capacity to lift and carry up to 25–50 pounds as required.
• Ability to communicate effectively via phone, video, and written communication.
• Occasional need to move about the office to access meetings or resources.

Nice To Haves

• Experience with post-market surveillance activities in accordance with IVDR regulations.
• Knowledge of auditing, statistics, and database management.

Responsibilities

• Compile, analyze, and report post-production information as part of the Post-Market Surveillance system.
• Lead ongoing Post Market Surveillance meetings for various product families.
• Assist in developing and updating policies and procedures as needed.
• Evaluate process effectiveness through KPI monitoring and risk assessments.
• Report issues to management to support timely resolution of customer complaints.
• Mentor team members on complaint handling processes and regulatory compliance requirements.
• Maintain collaborative relationships with peers and colleagues to support departmental objectives.
• Support complaint handling systems and post-market compliance programs.
• Interact with Regulatory Affairs, R&D, Manufacturing, Engineering, Quality Control, Supplier Quality, Incoming Inspection, Purchasing, and Technical Support teams.
• Perform other duties as assigned.

What This Job Offers

• Career Level: Mid Level