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!

Position Overview:  

This role oversees activities (defined below) related to the complaint determination process. This role will provide direction for individuals who evaluate product complaints. They will follow established global regulations for complaint handling.   

Responsibilities:  

• Mentor and help develop direct reports through yearly/quarterly reviews, weekly meetings, and daily interactions. 
• Support a positive culture with clear communication regarding goals and objectives. 
• Provide leadership to team members, including but not limited to, training support on processes and procedures. 
• Provide coaching and feedback in accordance with company SMART goals. 
• Establish / Track daily team metrics to ensure performance targets are achieved. 
• Promote industry best practices and standards through the use of metrics, dashboards and KPI scorecards 
• Manage direct reports to ensure the timely evaluation of cases. 
• Provide input to management to define reports/dashboards to identify delinquency or backlog in all aspects of the process. 
• Identify process improvement opportunities 
• Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2013, Canadian MDR, EU MDR and country specific vigilance related regulations. 
• Ensure compliance with quality standards. 
• Assists in the development of protocols and standards to meet quality specifications and recommends procedural changes. 

• Approve / Sign-off work of direct reports and other team members. 
• Performs other duties as assigned. 

Education and Experience:  

Bachelor’s degree preferred and 3-5 years of demonstrated experience in medical device post market surveillance 

Minimum Qualifications:   

Demonstrated medical device complaint evaluation 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 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:  

Experience in dealing directly with regulatory bodies is highly desired.  

diabetes experience preferred

Experience in technical writing 

Physical Requirements:  

General office environment – may sit for long periods of time.  

This position requires extensive computer use.  

May require international travel to the US