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Job Title: Manager of Post Market Compliance - Global Product Monitoring (GPM) FLSA Status: Exempt Company Overview Insulet started in 2000 driven to achieve our mission of enabling 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 who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it. Position Overview The Manager, Post Market Compliance-Global Product Monitoring (GPM) will report directly to the Senior Director of GPM-Safety & Surveillance and be responsible for the development, execution, oversight and maintenance of key aspects of Insulet’s Post Market Surveillance System consistent with applicable laws, industry standards and company policies. They demonstrate the ability to execute in a highly regulated, medical technology environment and willingness to perform hands-on, technical and operations work. They work with local and global cross-functional partners and external authorities to ensure effective post-market compliance. General Responsibilities <ul><li>Develops and maintains product knowledge of existing and new products. </li></ul><ul><li>Engages globally with internal stakeholders, developing and maintaining strong relationships to ensure effective processes while identifying improvements to drive efficiency and compliance. </li></ul><ul><li>Represents GPM at cross-functional, multi-level, and external meetings. </li></ul><ul><li>Adheres to all regulatory compliance and quality standards, including company policies and procedures and U.S. FDA, Health Canada, EU MDR, and other applicable quality system and country-specific regulations. </li></ul><ul><li>Maintains awareness of new or revised regulations, standards, and/or guidelines, particularly as they pertain to post-market vigilance and surveillance. </li></ul><ul><li>Reviews, evaluates and approves document changes, especially those concerning significant changes and revisions. Ensures required documentation, records, and reports are complete, accurate, and properly maintained. </li></ul><ul><li>Ensures key performance indicators are met or exceeded and works to continually drive down time-to-detect and time-to-resolve through improved detection and rapid response. </li></ul><ul><li>Performs other duties as required. </li></ul><ul><li>Reports to the Senior Director of GPM-Safety & Surveillance. </li></ul>Specific Responsibilities <ul><li>Ensure timely and effective management, preparation, and assembly of information for post-market requests for additional information (RFAIs) or other authority inquiries related to marketed products. </li></ul><ul><li>Author, co-author, and/or approve response communications to inquiries and requests from regulatory authorities around the world. </li></ul><ul><li>Engage with regulatory authorities beyond written communications as needed. </li></ul><ul><li>Serve as global process owner for RFAIs and drive global improvements of both the process and supporting technology based on performance data, authority trends, and industry practices. </li></ul><ul><li>Focus primarily on regions and markets outside of EMEA but will support EMEA as needed. Will work collaboratively with the French local contact for vigilance (matériovigilance). </li></ul><ul><li>Serve as subject matter expert and lead adoption of best practices as it pertains to regulatory writing and engagement with authorities on post-market matters. </li></ul><ul><li>Where appropriate, ensure escalation and cross-functional engagement with stakeholders around the world to enable rapid response to emerging issues and opportunities. </li></ul><ul><li>Where needed, advise on clinical/technical content in vigilance reports. </li></ul>Key Decision Rights <ul><li>Exercises judgment and discretion in matters of significant impact to the organization. </li></ul><ul><li>Leads and communicates with internal groups to gather necessary inputs and facts to execute clear decisions and actions. </li></ul><ul><li>Collaborates with internal groups to provide relevant and critical information to regulatory authorities as requested via RFAIs or other inquiries. </li></ul><ul><li>Identifies compliance risk exposures that may impact the achievement of company objectives. </li></ul><ul><li>Makes sound decisions with reasonable foresight as to potential compliance risks. </li></ul><ul><li>Provides input to conclusions to be included in complaint files, regulatory reports, RFAIs, and/or other regulatory authority-facing records. </li></ul>Required Leadership/Interpersonal Skills & Behaviors <ul><li>Leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement. </li></ul><ul><li>Builds strong relationships, demonstrating high emotional intelligence and ability to communicate clearly and persuasively </li></ul><ul><li>Flexibility in style to bring out the best in people with different backgrounds and working styles, while unifying them in purpose, role clarity, and expectations related to deliverables. </li></ul><ul><li>Comfortable with ambiguity and uncertainty; adapts nimbly and leads others through complex situations. </li></ul><ul><li>Seeks first to understand, actively listens, and analyzes information and data from a variety of sources to support decisions. </li></ul><ul><li>Effectively handles interactions at all levels and responds appropriately in sensitive situations. </li></ul><ul><li>Sense of urgency to drive actions in a prioritized manner. </li></ul><ul><li>Independent motivated self-starter, able to motivate others (particularly, influence without authority), and demonstrates a high level of reliability, integrity, and personal accountability. </li></ul><ul><li>Successively explains complex business and technical topics to both technical and non-technical audiences. </li></ul>Required Skills and Competencies <ul><li>Proven ability to: </li></ul><ul><li>Build solid, collaborative working relationships across all functions. </li></ul><ul><li>Produce results as a leader, individual contributor, and as a member of a team. </li></ul><ul><li>Exercise judgment against the criteria of applicable regulations and standards. </li></ul><ul><li>Rapidly learn and take advantage of new concepts and technologies. </li></ul><ul><li>Understand medical/clinical and technical aspects of product. </li></ul><ul><li>Quickly assimilate relevant information in unfamiliar situations, identify issues and root causes. Proven analytical, problem-solving, and critical thinking skills with the ability to synthesize complex data into actionable insights and solutions. </li></ul><ul><li>Acquire, query and analyze data with focus on detail. </li></ul><ul><li>Respond to emerging issues, manage team assignments, and provide timely direction. </li></ul><ul><li>Prioritize and direct limited resources to the most critical areas and issues. </li></ul><ul><li>Make commitments, set priorities, and deliver results on time and on budget </li></ul><ul><li>Communicate effectively with and influence people at all levels of the organization </li></ul><ul><li>Present and transfer knowledge. </li></ul><ul><li>Implement and maintain accurate documentation consistent with applicable quality standards. </li></ul><ul><li>Fluency in applicable regulations and standards. </li></ul><ul><li>Intermediate to advanced computer skills. </li></ul> <ul><li>Preferred Skills and Competencies: </li></ul><ul><li>Strong working knowledge of global medical device regulations and standards, including 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485 & 14971, EU MDR, CMDR, and other global regulations, standards, and guidelines (such as MDSAP, IMDRF, MDCG, MEDDEV). </li></ul> Education and Experience <ul><li>BS/BA degree with 8+ years’ work experience with at least 4 years’ experience in post-market surveillance or post-market vigilance in the MedTech industry. </li></ul><ul><li>Experience influencing without authority and facilitating cross-functional collaboration. </li></ul><ul><li>Experience managing cross-functional task- or project-focused teams on a global basis across different locations and cultures. </li></ul><ul><li>Proven experience responding to regulatory authority inquiries. </li></ul><ul><li>Preferred Experience: </li></ul><ul><li>In addition to the above, at least a general knowledge of: </li></ul><ul><li>diabetes and experience supporting technology and/or medicines related to diabetes. </li></ul><ul><li>SAMD and SIMD. </li></ul>Additional Information <ul><li>The position can be hybrid or in-person at our Acton, MA location. The preferred location is to be a commutable distance to Acton, MA. Will consider candidates that are a commutable distance to other Insulet locations. </li></ul><ul><li>Travel is estimated at 10-15% but will flex depending on business need. </li></ul><ul><li>Physical Requirements: General office environment; may sit or stand and use computer for long periods of time. </li></ul> NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-HybridAdditional Information:&#xa;&#xa;Compensation & Benefits:&#xa;&#xa;For U.S.-based positions only, the annual base salary range for this role is $112,300.00 - $168,400.00&#xa;&#xa;This position may also be eligible for incentive compensation.&#xa;&#xa;We offer a comprehensive benefits package, including:&#xa;• Medical, dental, and vision insurance&#xa;• 401(k) with company match&#xa;• Paid time off (PTO)&#xa;• And additional employee wellness programs&#xa;&#xa;Application Details:&#xa;This job posting will remain open until the position is filled.&#xa;To apply, please visit the Insulet Careers site and submit your application online.&#xa;&#xa;Actual pay depends on skills, experience, and education.<div>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.<div><div><div><div><div><div><div>(<a href="https://www.eeoc.gov/poster" target="_blank">Know Your Rights</a>)</div></div></div></div></div></div></div></div>

Manager, Post Market Compliance - Global Product Monitoring (Hybrid - Acton, MA)

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Insulet

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