Manager, Global Vigilance Writing (Remote/Flexible)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

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!

The Manager of Global Vigilance Writing 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

• Oversee the Global assessment, follow-up, coding, and vigilance activities for complaints determined to be reportable
• Ultimately responsible for oversight, peer review, and approval of vigilance reports to ensure on time submissions to the appropriate regulatory authorities.
• Manage the quarterly periodic summary reporting process
• Oversee the day-to-day vigilance reporting assignment; support management in day-to-day operations in a fast-paced work environment; lead day-to-day operational work distribution and end of day/week/month reconciliation.
• Lead, provide instruction, and feedback to the team as needed.
• 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 departmental non-conformances escalated into CAPA System
• Serve as a subject matter expert for post market and complaint handling regulatory questions and inquiries.
• Understand the principles of scientific writing, writing with the audience in mind, and conveying messages in a clear and concise manner. Analyzes, interprets, and distills data and other information to create vigilance reports.
• Apply comprehensive knowledge of relevant regulatory requirements and corporate policies to assess document requirements and identify information gaps or other potential issues. Takes appropriate risks to resolve any identified issues.
• Lead internal and external audits and inspections.
• Manage special projects as assigned
• Perform other duties as required

Education and Experience:

• Requires a Bachelor’s degree and 5 years of demonstrated experience in medical device complaint evaluation and reportability determination, or 5 years clinical experience in diabetes management or appropriate combination of relevant education and experience
• Prior management experience leading remote teams

Preferred Qualifications:

• 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.
• 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 leadership abilities and coaching for subordinate team members; 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.

Preferred Skills and Competencies:

• 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, prefe