Principal Regulatory Affairs Specialist

Stryker•Portage, MI

1d•Hybrid

About The Position

We are seeking a Principal Regulatory Affairs Specialist to join our Medical Division. This Hybrid role will be based in Portage, MI, offering the opportunity to combine on-site collaboration and remote flexibility. As the Principal Regulatory Affairs Specialist, you will develop and implement environmental compliance strategies to meet global, federal, and local regulations, including RoHS, REACH, WEEE, Proposition 65, EU MDD, and EU MDR. You will influence design and manufacturing processes for new product development and sustaining projects, resolve escalations, and manage day-to-day compliance issues such as tender requests, customer inquiries, and reporting.

Requirements

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.

Nice To Haves

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.

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.