Global Product Monitoring Vigilance Report Writer (Medical Devices)

Location: Paris, Île-de-France, France

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other wearable drug-delivery solutions.

What you will do

• Assess, follow up, code, and manage medical device complaints and reportable events globally.
• Author, peer review, and approve vigilance reports for timely submission to regulatory authorities.
• Collaborate with engineering, complaint investigation, medical, and other internal teams to review events, coding, and investigation results.
• Provide subject matter expertise on post-market surveillance, complaint handling, and regulatory questions.
• Support training, mentoring, audits, inspections, and special projects with minimal supervision.

Requirements

• Bachelor’s degree or an appropriate combination of relevant education and experience.
• Experience in medical device complaint triage and vigilance reporting, or clinical experience in diabetes disease management or diabetes device support.
• Direct experience writing and filing global medical device vigilance reports and understanding multi-country regulatory requirements.
• Strong analytical, organizational, communication, interpersonal, and documentation skills.
• Experience with Microsoft Office, complaint databases, and formal medical device quality management systems.
• Direct experience working with regulatory bodies and French vigilance requirements is required for the role.

Nice to have

• BSN with diabetes experience, or certification as a Registered or Licensed Dietitian or Diabetic Educator.
• Experience working with regulatory bodies and Prestataires.

Culture & Benefits

• Full-time role in a general office environment with extensive computer use.
• Up to 10% travel may be required.
• Opportunity to support quality and compliance initiatives across departmental, divisional, and corporate functions.