Post-Market Compliance Lead

NOVA Biomedical GmbH; Westbrook (ME); On-site; USD 70,000 - 95,000; Full time

Job summary

The Post Market Surveillance (PMS) Specialist role at Nova Biomedical offers an opportunity to ensure regulatory compliance across post-market activities for medical devices. You will prepare PMS reports, lead Post Market Surveillance meetings, and collaborate with Regulatory Affairs, R&D, Manufacturing, Engineering, Quality Control, and Purchasing to support complaint handling systems and KPI monitoring.

Training is required onsite for one week in Billerica.

Qualifications

• Bachelor’s degree in a scientific or technical discipline.
• Minimum of 3 years in medical device or diagnostic industries.
• Experience with MDRs/adverse event reporting to regulators.
• Experience with post-market activities per IVDR/fDA expectations preferred.
• SOPs in GMP environments; data analysis of quality/system data.

Responsibilities

• Prepare PMS reports and lead Post Market Surveillance meetings.
• Support complaint handling systems, policies, and KPI monitoring.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, and Quality teams.
• Mentor peers on complaint handling and regulatory requirements.
• Assist in developing and updating SOPs and procedures.

Skills

Regulatory compliance

Post-market surveillance

MDR reporting

Data analysis

Cross-functional collaboration

SOP development

Quality systems

Auditing knowledge

Education

Bachelor’s degree in a scientific or technical discipline

Job description

The Post Market Surveillance (PMS) Specialist role at Nova Biomedical offers an opportunity to ensure regulatory compliance across post-market activities for medical devices. You will prepare PMS reports, lead Post Market Surveillance meetings, and collaborate with Regulatory Affairs, R&D, Manufacturing, Engineering, Quality Control, and Purchasing to support complaint handling systems and KPI monitoring.

Training is required onsite for one week in Billerica.