Job Description

We are currently seeking a Senior Regulatory Affairs Specialist to join our Medical Division to be based Hybrid 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.).
• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.
• Evaluate proposed products for regulatory classification and jurisdiction.
• Determine requirements (local, national, international) and options 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.
• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
• Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools.
• Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions.
• Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process.
• Maintain current product registrations and assist to process registration changes when required.

What you need

• Bachelor’s degree in an Engineering, Science, or equivalent field.
• Minimum of 2 years of experience in an FDA or highly regulated industry required.
• Minimum of 1 year in a Regulatory Affairs role required.

Preferred

• RAC certification or Advanced Degree (Masters in Regulatory Affairs).
• Previous experience with Class II/III medical devices.
• Experience authoring regulatory submissions for product approval.
• Experience interacting with regulatory agencies.
• Previous experience with Class II/III medical devices.

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