Related content
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
The Principal Environmental Compliance Engineer (Hybrid) in the Medical Division supporting Stryker Sage products is an Individual Contributor responsible for developing, implementing, and maintaining policies and procedures to ensure compliance with relevant environmental statutes and regulations. This role conducts product material assessments, oversees the timely completion of corrective actions, and maintains required documentation. It investigates and resolves compliance concerns, and inquiries, from internal teams, customers, and regulatory agencies. Additionally, the position designs and delivers programs to increase employee awareness of compliance policies and assesses existing policies, procedures, and documentation for alignment with applicable laws and regulations.
The role requires the candidate to reside within a commutable distance to Cary, IL, with an expectation to be onsite 3-4 days per week.
What you will do
- Lead initiatives aimed at the reduction of chemicals of concern, packaging, and decarbonization of operations, as well as throughout the supply chain
- Launch and maintain a software solution to streamline substance data acquisition and compliance/conformance report generation
- Establish working relationships and interface with multiple government and non-government organizations having an impact on market access and distribution
- Assess requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develop solutions to address anticipated obstacles
- Provide regulatory oversight by reviewing product/packaging materials, SOPs, change requests, and/or deviations for environmentally preferred purchasing (EPP) program and product environmental compliance (PEC)
- Prepare and distribute documentation on safety, intended use, shelf life of drugs, medical devices and/or cosmetics as needed
- Critically assess, develop and implement strategies based on the impact of EPP and PEC on business strategies and product lifecycle approaches.
- Review advertising and promotional materials, for conformance to EPP and PEC requirements as assigned
- Collaborate with the Divisional Process Owner (DPO) and other Site Process Owners (SPOs) on process improvements and updates related to EPP and PEC
- Support the preparation of US and International regulatory applications, including supplements/variations, and correspondence to FDA, Health Canada, and/or other regulatory authorities
What you will need
- BS in Engineering, Science, or related Advanced degree
- A minimum of 8 years’ experience in a Regulatory Affairs, Quality Assurance, or Engineering environment.
Preferred
- MS in Regulatory Science or Engineering
- 8 years of experience managing the development and execution of new regulatory procedures and standard operating procedures (SOPs).
- Working knowledge in EPP and PEC requirements