Description

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

We are looking for a self-motivated Product Environmental Compliance Specialist to join the Insulet team. This position will be responsible for monitoring global environmental product regulations, interpreting and communicating scope and impacts of these regulations on our business, and supporting compliance activities. You must be able to define regulatory requirements for the business, support the execution of compliance, and monitor management systems required for compliance. You will work closely with Regulatory, Sustainability, Engineering, Market Access, and Quality departments to ensure functional business owners understand existing environmental product requirements, upcoming requirements, trends, gaps, and regulatory risk that may impact product decisions and/or market access.

The Product Environmental Compliance Specialist needs to thrive in a fast-paced hypergrowth environment, communicate clearly, early and frequently, demonstrate the ability to execute in a deadline-driven environment, and be able to influence change beyond requirements. We are passionate about our customers and products, people, communities, and our planet. We embrace and celebrate diversity and differences including diverse experiences and backgrounds that you may bring to the position. We strive to work with people who are intellectually curious, forward thinking and ready to make an impact.

Duties and Responsibilities:

• Manage all applicable environmental regulations across legacy, existing, and new products.

• Provide guidelines, best practices, communication, and support to organizations across the business as the environmental product compliance subject matter expert

• Provide regulatory guidance to global Insulet sites and appropriate business owners on compliance to local product environmental regulations

• Lead all product environmental stewardship registrations and permitting applications including any required reporting with support from Regulatory Affairs team and other relevant cross functional teams.
• Manage execution of compliance by working with internal business owners to develop reports, collect data, and submit to local regulatory authorities per local regulations

• Respond to inquiries from external stakeholders related to environmental compliance.

• Partner with Quality and Engineering to ensure a cohesive approach toward product requirements definition and quality management
• Develop long range plans to support Product environmental stewardship compliance strategy.
• Advances Insulet's objectives on Product Stewardship with agencies, trade associations, peer companies and governmental organizations through advocacy.
• Mentor others by sharing knowledge expertise and providing feedback and guidance.

Preferred Skills and Competencies:

• Strong understanding of consumer electronic products, medical devices, and packaging-related environmental regulations and standards. Some specific regulations include: Global environmental material/substance regulations, Global ROHS, Global REACH, REACH SCIP Database, CA Prop 65, Global WEEE, TSCA, etc.
• Understanding of other material regulations and restrictions (i.e. PFAS, HFR/BFR's, etc.)
• Understanding of global product stewardship requirements (i.e. Global EPR, takeback, and recycling)
• Understanding of environmental battery regulations/requirements (i.e. EU Battery Directive)
• Understanding of market access environmental requirements (i.e. pharmacy store/shelf packaging requirements)
• Demonstrated experience working with Nationally Recognized Testing Laboratories (NRTLs) or taking products through the certification process
• Strong understanding of reading regulations and understanding FDA Requirements, including proper document control
• Familiarity with best practices when implementing compliance processes and procedures
• Independence - Act independently while taking guidance and general direction from the manager.
• Planning/Organizing - Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
• Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
• Project Management - Communicates changes and progress.

Education & Experience:

• Bachelor of Science in Electrical Engineering, Materials Engineering, Chemical Engineering, Material Science or equivalent
• Master's in policy, materials, engineering, or related field preferred

• 3-7 years of related work experience in regulatory or product compliance

• Experience in Medical Devices, Pharmaceutical, Electronics or related industry preferred
• Strong understanding of EU CE Marking process and how it ties into medical device CE marking

• PLM system experience (Arena preferred)
• Database management experience
• Proficient in MS Office products, Outlook, Word, Excel, PowerPoint, and Project as well as familiarity with Smartsheets

Physical Requirements:

• Travel - 0-10%
• Hybrid role.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:
Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $89,400.00 - $134,100.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.

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 tu beless 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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