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

• Bachelors 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.

• Masters 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.