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Staff Specialist, Regulatory Affairs

Company

Stryker

Location

Mahwah, United States

Type

Full-time

Stryker is hiring a **Staff Regulatory Affairs Specialist** in **Mahwah, NJ** to support **new product development** for our **Joint Replacement implant and instrument portfolio** across U.S and international markets **.** This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.

**What you will do**

+ Assess regulatory intelligence and update local, regional, and global regulatory strategies based on evolving requirements
+ Evaluate the regulatory environment and provide guidance across product lifecycle phases including development, manufacturing, and commercialization
+ Determine product classification, submission requirements, and approval pathways across domestic and international markets
+ Prepare and submit regulatory filings in accordance with applicable global regulations and timelines
+ Identify regulatory risks and o...

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