Job Description

We are currently seeking a Regulatory Affairs Specialist to join our Medical Division , Hybrid , to be based in Redmond, Washington .

What you will do

As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market and ensure ongoing compliance. In this role, you will:

• Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers
• Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
• Evaluate proposed products for regulatory classification and jurisdiction
• Determine requirements and strategy for regulatory submission, approval pathways, and compliance activities
• Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products.
• Monitor the progress of the regulatory authority review process through appropriate communications with the agency
• Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools
• Maintain current product registrations and assist to process registration changes when required.
• Perform timely reviews of collateral material for responsible product lines.
• Build relationships and interface with cross-functional teams (Engineering, International RA, Manufacturing, Marketing, etc.) to ensure accurate, complete, and timely submission preparation.
• Perform other duties as assigned by manager.

What you need

• Bachelor’s degree in an Engineering, Science, or equivalent field
• 0-2 years in a Regulatory Affairs role
• Previous experience with Class II/III medical devices

Preferred

• Experience authoring regulatory submissions for product approval
• Experience interacting with regulatory agencies
• A passion for compliance and process driven style of working
• Excellent communication skills, ability to influence others and clearly give and receive instructions and direction
• Strong organizational and analytical skills

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