Insulet

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Senior Supervisor, Global Product Monitoring (Remote/Flexible) (Finance)



The Senior Supervisor, Global Product Monitoring role oversees activities (defined below) related to the complaint evaluation process. This role will provide direction for individuals who evaluate and process 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
  • Oversee Complaint evaluation and processing in compliance with FDA, Health Canada and EU MDR Quality System Regulations and country specific regulations.
  • Manage direct reports to ensure the timely evaluation of customer complaints.
  • 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.

Minimum Qualifications:

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

Preferred 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.
  • Experience in dealing directly with regulatory bodies is highly desired.
  • BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred
  • Experience in technical writing

Physical Requirements:

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

Additional Considerations:

  • Remote/Flexible
  • Preferred Time Zones: CST and EST
  • May require 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:
The US base salary range for this full-time position is $92,925.00 - $139,387.50. 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.

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!

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

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