Senior Regulatory Affairs Specialist (Hybrid)

Stryker; Washington (District of Columbia); Hybrid; USD 96,000 - 160,000; Full time

Job summary

Stryker's Emergency Care division seeks a Senior Regulatory Affairs Specialist to support medical device compliance and market access. The role involves regulatory assessments, strategy development, and submission management across the product lifecycle in a hybrid position based in Redmond, WA.

The candidate will evaluate proposed changes, identify market access requirements, and prepare regulatory submissions while maintaining registrations with authorities.

Qualifications

• Bachelor's degree in an engineering/science/regulatory field or related technical discipline.
• At least 2 years of regulatory affairs experience required.
• Experience with FDA or other highly regulated medical device environments preferred.
• Knowledge of medical device classifications and regulatory pathways.
• Ability to prepare regulatory submissions and communicate with authorities.

Responsibilities

• Evaluate product changes for regulatory implications and compliance requirements.
• Identify market access requirements across federal, state, and reimbursement channels.
• Develop regulatory strategy based on evolving requirements.
• Prepare and submit electronic and paper regulatory submissions to authorities.
• Maintain product registrations and process registration changes.

Skills

Regulatory affairs

Communicating with authorities

Regulatory strategy development

Education

Bachelor's degree in Engineering, Science, Regulatory Affairs, or related technical field

Job description

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