Post-Market Surveillance Lead: Compliance & Insights

NOVA Biomedical GmbH; Norwood (MA); On-site; USD 55,000 - 83,000; Full time

Job summary

Nova Biomedical Corporation seeks a Contract Post Market Surveillance Specialist to lead post-market activities, compile and analyze post-production information, and ensure compliance with global regulations. The role collaborates with Regulatory Affairs, R&D, and Manufacturing to drive continuous improvement.

The ideal candidate has 3+ years in medical devices, experience with MDRs/adverse event reporting, and familiarity with IVDR and GMP SOPs.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 3+ years in the medical device or diagnostic industry.
• 2+ years in post-market surveillance, complaint handling, customer support, or quality assurance in a medical device environment.
• Experience submitting Medical Device Reports (MDRs) or adverse event reports to regulatory agencies.
• Experience with post-market surveillance activities in accordance with IVDR preferred.
• Experience writing SOPs in a GMP environment.
• Experience analyzing post-market, quality data, or regulatory data.
• Medical device experience in FDA-regulated environments.
• Knowledge of auditing, statistics, and database management preferred.

Responsibilities

• Compile, analyze, and report post-production information for the Post-Market Surveillance system.
• Lead ongoing Post Market Surveillance meetings for product families.
• Develop and update policies and procedures as needed.
• Evaluate effectiveness via KPI monitoring and risk assessments.
• Report issues to management to support timely resolution of customer complaints.
• Mentor team members on complaint handling and regulatory compliance.
• Maintain collaborative relationships with peers 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, Purchases, and Technical Support teams.
• Perform other duties as assigned.

Skills

Regulatory compliance

Data analysis

Auditing

Medical devices

IVDR knowledge

Education

Bachelor's degree

Job description

Nova Biomedical Corporation seeks a Contract Post Market Surveillance Specialist to lead post-market activities, compile and analyze post-production information, and ensure compliance with global regulations. The role collaborates with Regulatory Affairs, R&D, and Manufacturing to drive continuous improvement.

The ideal candidate has 3+ years in medical devices, experience with MDRs/adverse event reporting, and familiarity with IVDR and GMP SOPs.