Senior Regulatory Affairs Specialist (Hybrid)

About the role

Stryker's Medical Division supports Emergency Care. As a Senior Regulatory Affairs Specialist based in Redmond, Washington (hybrid), you will help ensure the continued compliance, registration and market availability of medical devices throughout their lifecycle, working with cross-functional teams on product changes and regulatory activities.

Key responsibilities

• Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers.
• Identify requirements and potential obstacles for market access, including federal, provincial/territorial, reimbursement and purchasing group rules.
• Help develop and update regulatory strategy in line with regulatory changes.
• Evaluate proposed products for regulatory classification and jurisdiction, and determine submission requirements and approval pathways.
• Prepare and submit electronic and paper regulatory submissions.
• Provide regulatory guidance to product development and planning teams throughout the product lifecycle.
• Communicate with regulatory authorities during the review of submissions and evaluate pre-clinical, clinical and manufacturing changes.
• Monitor and submit reports or notifications during clinical research, and maintain product registrations.

Required profile

• Bachelor's degree; preferred in Engineering, Science, Regulatory Affairs or a related technical field.
• At least 2 years in a Regulatory Affairs role.
• Experience in an FDA-regulated or highly regulated industry.
• Preferred: experience with Software as a Medical Device (SaMD) products, previous work with Class II/III medical devices, experience authoring regulatory submissions, and experience interacting with regulatory agencies.
• RAC certification or an advanced degree (Master's in Regulatory Affairs) preferred.