Regulatory Affairs Specialist: MedTech & SaMD

Stryker; Redmond (WA); On-site; USD 110,000 - 183,000; Full time

Job summary

Stryker is seeking a Staff Regulatory Affairs Specialist in Redmond, WA to guide regulatory activities across product development, changes, and lifecycle management. You will partner with cross-functional teams to ensure compliance and market availability while communicating with regulatory authorities.

The role emphasizes collaboration, regulatory strategy development, and handling submissions across a complex product portfolio including software and devices.

Qualifications

• Bachelor’s degree in engineering, science, regulatory affairs, or related technical field.
• Minimum 4 years of regulatory affairs experience in regulated industry.
• Experience authoring and managing regulatory submissions.

Responsibilities

• Support regulatory assessments of proposed product changes and software updates for R&D, Marketing, and Manufacturing.
• Support sustaining regulatory activities across a complex portfolio to ensure compliance and market availability.
• Identify regulatory requirements and potential barriers to market access and product distribution.
• Develop regulatory strategies for product development and lifecycle management.
• Evaluate products for regulatory classification, jurisdiction, and pathways.
• Prepare and submit regulatory filings per applicable guidelines.
• Provide regulatory guidance for development, lifecycle management and product changes.
• Communicate with regulatory authorities during submission development, review and approval.
• Evaluate pre-clinical, clinical, manufacturing, and software changes to recommend filing strategies.
• Maintain product registrations and support required updates, reports, and notifications.
• Assist in developing procedures, work instructions, and stakeholder training on compliance.

Job description

Stryker is seeking a Staff Regulatory Affairs Specialist in Redmond, WA to guide regulatory activities across product development, changes, and lifecycle management. You will partner with cross-functional teams to ensure compliance and market availability while communicating with regulatory authorities.

The role emphasizes collaboration, regulatory strategy development, and handling submissions across a complex product portfolio including software and devices.