Staff Regulatory Affairs Specialist (Hybrid)

About the role

Stryker's Medical Division supports Emergency Care as a Staff Regulatory Affairs Specialist based in Redmond, Washington. The role guides regulatory activities across product development, product changes and lifecycle management, partnering with cross-functional teams to provide regulatory guidance and help ensure ongoing compliance and market availability. The position is hybrid.

Key responsibilities

• Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed product changes, software updates and product transfers.
• Maintain regulatory compliance and product availability across a complex portfolio of products, and implement product and process changes.
• Identify regulatory requirements and potential barriers to market access and product distribution.
• Develop and refine regulatory strategies in response to product changes and evolving requirements.
• Evaluate products for regulatory classification, jurisdiction and applicable pathways.
• Prepare and submit regulatory filings in line with agency guidelines.
• Provide regulatory guidance for product development, lifecycle management and planned changes.
• Communicate with regulatory authorities during submission development, review and approval.
• Evaluate pre-clinical, clinical, manufacturing and software changes and recommend filing strategies.
• Maintain product registrations and support registration updates, reports and notifications.
• Help develop procedures, work instructions and stakeholder training on regulatory requirements.

Required profile

• Bachelor's degree required; preferred in Engineering, Science, Regulatory Affairs or a related technical field.
• Minimum 4 years of Regulatory Affairs experience in a medical device, pharmaceutical, biotechnology or other highly regulated industry.
• Experience authoring and managing regulatory submissions, registrations or product approvals.
• Preferred: experience with Class II and/or Class III devices, SaMD products, regulatory strategy development, RAC certification or a master's in Regulatory Affairs.

Required skills

• Strong communication skills, able to explain regulatory requirements to technical and non-technical stakeholders.

What we offer

• Pay range of $110,100 - $183,400 USD annually depending on location.
• 10% travel.