Regulatory Affairs Specialist

Join Stryker as a Regulatory Affairs Specialist in Portage, MI supporting Instruments – Surgical Technologies. This role will support regulatory activities for the Neptune Waste Management System, ensuring continued market access, compliance, and lifecycle management across global markets. You will partner with cross-functional teams to evaluate product changes, maintain regulatory approvals, and support strategic initiatives that enable ongoing commercialization, refurbishment, and expansion efforts.

What you will do

• Assess regulatory intelligence and summarize implications for local, regional, and global regulatory strategies.

• Evaluate product and process changes for regulatory impact across the device lifecycle, including updates, enhancements, and maintenance activities.

• Identify regulatory risks and propose mitigation plans throughout the product lifecycle.

• Partner with cross-functional teams (R&D, Quality, Marketing) to ensure alignment of regulatory requirements and claims strategy.

• Prepare, review, and support submission of regulatory filings for product changes, global registrations, and lifecycle management activities.

• Monitor regulatory submissions and communicate status updates to internal stakeholders and regulatory authorities.

• Review marketing and promotional materials to ensure compliance and alignment with approved regulatory claims.

• Support development and maintenance of a centralized claims library to enable compliant and efficient marketing updates.

• Support state licensing and other regulatory compliance activities as needed.

What you will need

Required

• Bachelor’s degree required. Preferred to be in Engineering, Science, or related field.

• Minimum 0 years of experience in regulatory affairs.

Preferred

• 2+ years of experience in regulatory affairs preferred.

• Master’s degree in Regulatory Science.

• Regulatory Affairs Certification (RAC).

• Demonstrated experience (academic, internship, or co-op) supporting regulatory documentation, submissions, or compliance activities in a regulated environment.

• Experience interacting with regulatory authorities (e.g., FDA, EU Competent Authorities).

• Experience interpreting and applying regulatory requirements across product lifecycle stages.