Global Product Monitoring Vigilance Report Writer

Role Overview

• Responsible for the assessment, follow-up, coding, and vigilance activities for complaints globally.
• Author, peer review, and approve vigilance reports to ensure on time submissions to the appropriate regulatory authorities.
• Support management in day-to-day operations in a fast-paced work environment; Support proper coding of complaints and reportable events.
• Collaborate with engineering, complaint investigation laboratory, medical and other internal staff to review events, coding, and investigation results to support regulatory reporting compliance.
• Contribute to departmental non-conformances escalated into CAPA System.
• Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries.
• Support internal and external audits and inspections.
• Assist with special projects, as assigned, with minimal supervision.
• Perform other duties as required.

Requirements

• Bachelor’s degree or appropriate combination of relevant education and experience.
• Demonstrated experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support.
• Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.
• Effective verbal and written communication skills.
• Ability to generate, verify, and maintain accurate records.
• Must have analytical skills, be detail oriented, and have good interpersonal skills.
• Demonstrated ability to influence without authority.
• Ability to organize, judge priorities, and escalate when applicable.
• Strong emphasis and understanding of a formalized medical device Quality Management System.
• Direct experience of writing and filing global vigilance reports within the medical device industry.
• Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements.
• Experience in dealing directly with regulatory bodies is highly desired.
• BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred.

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs