Post-Market Surveillance Lead

novabio; Waltham (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Nova Biomedical in Billerica, MA is seeking a Post Market Surveillance Specialist to lead reporting, meetings, and compliance activities within the Post Market department.

You will collect and analyze post-production information, develop SOPs, monitor KPIs, and support regulatory submissions such as MDRs.

Collaborate with Regulatory Affairs, R&D, Manufacturing, and Quality teams to ensure adherence to FDA and IVDR requirements and maintain a compliant quality system.

Qualifications

• 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 with post-market surveillance activities in accordance with IVDR regulations preferred.
• 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.

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.

Skills

PMS reporting

Regulatory compliance

MDR reporting

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in a scientific or technical discipline

Job description

Nova Biomedical in Billerica, MA is seeking a Post Market Surveillance Specialist to lead reporting, meetings, and compliance activities within the Post Market department.

You will collect and analyze post-production information, develop SOPs, monitor KPIs, and support regulatory submissions such as MDRs.

Collaborate with Regulatory Affairs, R&D, Manufacturing, and Quality teams to ensure adherence to FDA and IVDR requirements and maintain a compliant quality system.