Work Flexibility: Hybrid or Onsite
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 inspections, oversees the timely completion of corrective actions, and maintains required documentation. It investigates and resolves compliance concerns, inquiries, or complaints from internal teams, customers, and regulatory agencies. Additionally, the position designs and delivers programs to increase employee awareness of compliance policies and audits 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 labeling changes, 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
- Critically assess the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
- Review advertising and promotional materials, for conformance to claims, applicable regulations and medical requirements as assigned
- Collaborate with the Divisional Process Owner (DPO) and other Site Process Owners (SPOs) on process improvements and updates related to product environmental compliance
- Manage the preparation, submission, and maintenance of US and International regulatory applications, including supplements/variations, annual reports, 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
- 8 years of experience managing the development and execution of new regulatory procedures and standard operating procedures (SOPs).
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
