Post‑Market Surveillance Lead & Analytics

Nova Biomedical; Waltham (MA); On-site; USD 90,000 - 125,000; Full time

Job summary

Nova Biomedical is seeking a Post Market Surveillance Specialist to prepare reports, lead PMS meetings, and support compliant post-market activities across product families in a regulated environment.

The role requires at least three years in the medical device or diagnostic industry, with experience in systematic data analysis, SOPs, and regulatory reporting. Collaboration with Regulatory Affairs, R&D, and Quality teams is essential.

Qualifications

• Bachelor’s degree in a scientific or technical discipline is required.
• Minimum of three years in medical device/diagnostic field.
• Experience with post-market surveillance, complaint handling, and QA in a medical device environment.
• Experience submitting MDRs or adverse event reports to regulators is preferred.

Responsibilities

• Prepare Post-Market Surveillance reports and collect post-production information.
• Lead Post Market Surveillance meetings for product families.
• Assist in developing and updating policies and procedures for PMS.
• Evaluate processes via KPI monitoring and risk assessments.
• Report issues to management to support timely customer complaint resolution.
• Mentor team members on complaint handling and regulatory compliance.

Skills

Regulatory compliance

Quality assurance

Data analysis

Cross-functional teamwork

Medical device industry experience

Education

Bachelor’s degree in sciences or engineering

Tools

Regulatory databases

SOP development

Job description

Nova Biomedical is seeking a Post Market Surveillance Specialist to prepare reports, lead PMS meetings, and support compliant post-market activities across product families in a regulated environment.

The role requires at least three years in the medical device or diagnostic industry, with experience in systematic data analysis, SOPs, and regulatory reporting. Collaboration with Regulatory Affairs, R&D, and Quality teams is essential.