Senior Regulatory Affairs Specialist (Hybrid)
$95.8k - $159.6kStryker Corporation
Senior Regulatory Affairs Specialist supporting medical device compliance and market access at Stryker's Emergency Care division. The role involves regulatory assessments, strategy development, and submission management across the product lifecycle in a hybrid position based in Redmond, Washington.
Responsibilities
- Evaluate proposed product changes and transfers for regulatory compliance requirements
- Identify market access requirements across federal, state, and reimbursement channels
- Develop and update regulatory strategy based on changing requirements
- Prepare and submit electronic and paper regulatory submissions to authorities
- Maintain current product registrations and process registration changes
Requirements
- Bachelor's degree in Engineering, Science, Regulatory Affairs, or related technical field
- Minimum 2 years regulatory affairs experience
- FDA or highly regulated industry experience
- Knowledge of medical device classification and regulatory pathways
- Ability to prepare regulatory submissions and communicate with authorities
Compensation: $95,800 - $159,600 USD Annual
Vacancy posted 25 days ago
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