Stryker ยท 1 day ago
Principal Regulatory Affairs Specialist
Portage, MI
Full-time
Hybrid
Lead/Staff
9+ years expStryker is seeking a Principal Regulatory Affairs Specialist to join their Medical Division. This role involves developing and implementing environmental compliance strategies to meet various regulations, influencing design and manufacturing processes, and managing compliance issues for new product development and sustaining projects.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Develop and implement global product environmental compliance strategies to meet international, federal, state, and local regulations (e.g., RoHS, REACH, WEEE, Proposition 65, EU-MDR)
Own and manage the Environmental Compliance Process for Acute Care and Emergency Care business units
Lead cross-functional teams to ensure compliance requirements are integrated into new product development and sustaining projects
Influence design and manufacturing processes to meet environmental compliance standards and drive process improvements
Engage and guide suppliers in developing environmentally compliant processes and controls for new and existing products
Oversee compliance technology systems for tracking, reporting, and maintaining environmental stewardship programs
Monitor and assess emerging regulations and trends, driving necessary changes into product development and sustaining plans
Prepare and submit regulatory reports (e.g., WEEE, Battery, Packaging) and respond to audits, inspections, and customer questionnaires
Train, communicate, and document compliance programs across global teams to ensure sustainable and effective processes
Present compliance risks during project reviews and provide objective evidence for design verification and validation deliverables
Qualification
Required
Bachelor's degree in Engineering, Science, or a related field (B.S. or B.A.)
Minimum 9 years of experience in a regulated industry
Thorough knowledge of FDA and international medical device regulations
Preferred
At least 5 years in medical industry, Regulatory Affairs or Engineering
RAC certification or Advanced Degree (Master's in Regulatory Affairs)
Previous experience drafting regulatory submissions
Experience interacting with regulatory agencies
Strong ability to analyze complex compliance challenges and provide solutions
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chief Executive Officer
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase