Regulatory Quality Lead - Medical Device Complaints

LanceSoft Inc; Raritan (NJ); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading regulatory affairs company in Raritan, New Jersey, is looking for a Customer Quality Specialist. This role focuses on supporting Post Market Regulatory Affairs activities, including complaint handling and regulatory reporting. The ideal candidate should have a Bachelor’s degree and 2-4 years of relevant experience. Key responsibilities involve submitting regulatory reports accurately, collaborating with various stakeholders, and participating in complaint investigations. This position offers opportunities to engage in projects and achieve productivity and accuracy targets.

Qualifications

• 2-4 years of related work experience required.
• RAC or ASQ certifications are a plus.

Responsibilities

• On-time submission and accuracy of regulatory reports.
• Review Medical Device Reports and Vigilance Reports.
• Interface with service centers and Hospitals for complaints.
• Participate in various projects and events.

Skills

Regulatory reporting

Complaint handling

Investigation

Collaboration

Knowledge of global regulations

Education

Bachelor’s Degree

Job description

A leading regulatory affairs company in Raritan, New Jersey, is looking for a Customer Quality Specialist. This role focuses on supporting Post Market Regulatory Affairs activities, including complaint handling and regulatory reporting. The ideal candidate should have a Bachelor’s degree and 2-4 years of relevant experience. Key responsibilities involve submitting regulatory reports accurately, collaborating with various stakeholders, and participating in complaint investigations. This position offers opportunities to engage in projects and achieve productivity and accuracy targets.