Post Market Surveillance Specialist

Nova Biomedical Corporation • Waltham, MA

4d • Hybrid

About The Position

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

Requirements

• Bachelor’s degree in a scientific or technical discipline.
• Minimum of three years of experience within the medical device or diagnostic industry.
• Minimum of 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 required.
• Experience working within FDA-regulated or other regulated environments.

Nice To Haves

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

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 the effectiveness of current processes 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 activities related to 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.

Benefits

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program
• Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level