Regulatory Affairs Specialist

Stryker • Portage, MI

1d • $72,500 - $120,900 • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree required, preferably in Engineering, Science, or related field.
• Minimum 0 years of experience in regulatory affairs.
• 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.

Nice To Haves

• 2+ years of experience in regulatory affairs preferred.
• Master’s degree in Regulatory Science.
• Regulatory Affairs Certification (RAC).

Responsibilities

• 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.

Benefits

• 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.
• Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
• We are proud to be named one of the World’s Best Workplaces!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level