Manager, Complaint Evaluation (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.

The Manager of Complaint Evaluation develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory and client requirements; serves as a complaint evaluation and reportability determinations 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

• Lead the evaluation, follow-up, coding, and investigation process for complaints
• Lead the reportability determination assessment process to identify reportable complaints globally
• Manage day-to-day complaint 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.
• Collaborate, provide instruction, and feedback to the team as needed.
• 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
• Lead or contribute to departmental non-conformances escalated into CAPA System
• Develop and deliver appropriate training (i.e., process, complaint handling, and regulatory reporting) to complaint management system end users
• Serve as a subject matter expert for post market and complaint handling regulatory questions and inquiries.
• Support internal and external audits and inspections.
• Manage special projects as assigned with minimal supervision
• Perform other duties as required

Education and Experience:

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

Minimum 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 complaint evaluation and reportability determination within the medical device industry
• Ability to communicate at multiple levels of an organization.
• Experience in dealing directly with regulatory bodies is highly desired
• BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred

Physical Requirements:

• General office environment – may sit for long periods of time.
• This position requires extensive computer use.
• May involve up to 10% travel

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote  

Additional Information: