Senior Global Product Monitoring Vigilance Report Writer (Remote/Flexible)

The Senior Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities; works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; demonstrates good judgment in selecting methods and techniques for obtaining solutions; and networks with senior internal and/or external personnel in own area of expertise.

Key Responsibilities:

• Responsible for the assessment, follow-up, coding, and vigilance activities for complaints determined to be High-Priority for the US FDA and other countries.
• 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 as applicable to review events, coding, and investigation results to support regulatory reporting compliance occurs per procedures, standards, and regulations.
• Lead or 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.

Minimum Qualifications:

• Bachelor’s degree and 5 years of demonstrated experience in medical device complaint triage and vigilance reporting or 5 years clinical experience in diabetes disease management or diabetes device support or appropriate combination of relevant education and experience. 

Preferred Skills and Competencies:

• Demonstrated medical device complaint handling and vigilance reporting experience.
• Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements.
• Direct experience of 5 or more years in writing and filing global vigilance reports within the medical device industry.
• Experience in dealing directly with regulatory bodies is highly desired.
• BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred.
• Strong emphasis and understanding of a formalized medical device Quality Management System.
• 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 proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.

Physical Requirements:

• General office environment – may sit for long periods of time.
• This position requires extensive computer use.

Additional Considerations:

• Remote/Flexible

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

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