Senior Product Environmental Compliance Specialist (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

78d•Hybrid

About The Position

We are looking for a self-motivated Senior 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 Senior 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.

Requirements

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 - Plan, track and communicates changes and progress.
Bachelor of Science in Electrical or Mechanical Engineering, Materials Engineering, Chemical Engineering, Material Science or equivalent
5 years or more 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

Nice To Haves

Master's in policy, materials, engineering, or related field preferred

Responsibilities

Manage all applicable environmental regulations for new and entire lifecycle of various 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.