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Senior Regulatory Affairs Specialist

Company

Stryker

Location

Greenwood Village, United States

Type

Full-time

Stryker is hiring a **Senior Regulatory Affairs Specialist** to support **Sports Medicine** in **Denver, CO** ! In this role, you will develop and implement regulatory strategies, ensure compliance across the product lifecycle, manage regulatory submissions, advise stakeholders on regulatory requirements, and engage with regulatory authorities to resolve issues and support market access.

**What you will do:**

+ Develop and update regulatory strategies at the local, regional, and global levels by monitoring regulatory intelligence and emerging requirements.
+ Determine product classification, submission requirements, and approval pathways, preparing and submitting regulatory filings in alignment with applicable guidelines.
+ Assess the regulatory landscape and provide guidance across the product lifecycle to support compliant development, manufacturing, and commercialization.
+ Identify potential regulatory obstacles, anticipate upcoming issues, and recom...

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