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 Sr. Post Market Surveillance Specialist 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
• Lead the review, follow-up, and investigation process for complaints that are a part of the Critical Complaint Triage process.
• Lead 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.
• Manage the quarterly periodic summary reporting process
• Assist with 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 to support regulatory reporting compliance occurs per procedures, standards, and regulations.
• 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 3 years of demonstrated experience in medical device complaint triage and vigilance reporting.
• OR an Associate’s degree and 5 years of demonstrated experience in medical device complaint triage and vigilance reporting.
• OR a high school diploma and 7 years of demonstrated experience in medical device complaint triage and vigilance reporting.

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 complaint analytics and metric trending skills.
• Excellent written and verbal communication skills.
• 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.
• Minimum 5 years of medical device industry experience.
• Ability to communicate at multiple levels of an organization.
• Experience in dealing directly with regulatory bodies is highly desired.
• BSN, Registered Dietician or Diabetic Educator 3 years plus

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

Additional Considerations
• Remote/Flexible
• Primary Job Posting: United States
• Additional Job Posting Locations: France, Germany, United Kingdom

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).

Additional Information

The US base salary range for this full-time position is $82,400.00 - $123,800.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, ****** orientation, gender identity, national origin, disability, or status as a protected veteran.

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