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Regulatory Affairs Specialist at Stryker - ApplyBlast

Regulatory Affairs Specialist

Stryker

4 months ago

4.0 on Glassdoor

Portage, Michigan

Hybrid

Full Time

Junior

0 applicants

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About this role

A Regulatory Affairs Specialist at Stryker supports the Instruments Surgical Technologies division by managing regulatory activities, lifecycle management, and market access for products like the Neptune Waste Management System. The role involves evaluating product changes, preparing regulatory filings, ensuring compliance across global markets, and partnering with cross-functional teams to maintain approved regulatory claims and strategies.

Responsibilities

Assess regulatory intelligence and summarize implications for global strategies
Evaluate product and process changes for regulatory impact across the lifecycle
Prepare and support submission of regulatory filings for global registrations
Review marketing materials to ensure compliance with approved regulatory claims
Partner with cross-functional teams to align regulatory requirements and claims strategy

Skills

Qualifications

Bachelor's degree in Engineering, Science, or related fieldMaster's degree in Regulatory Science (Preferred)Regulatory Affairs Certification (RAC) (Preferred)

About Stryker

stryker.com

Headquarters

Portage, Michigan, United States

Company Size

10001+ employees

Founded

1941

View Profile

Stryker is a global medical technology company that develops and sells a broad range of medical devices, equipment, and services. The company serves healthcare markets across the Americas, Asia Pacific, Europe, and the Middle East & Africa. Stryker's products span areas including surgical equipment, orthopedics, and medical instruments.