Senior Regulatory Affairs Specialist

Stryker

. Support R&D, Marketing, and Manufacturing teams with regulatory assessments of proposed changes or product transfers .

Posted 10/5/2026full-timeRedmond • Washington • United StatesSenior💰 $95,800 - $159,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy development, submission preparation, and compliance activities for medical devices and software as a medical device (SaMD) products. Proficient in interacting with regulatory authorities and maintaining product registrations throughout the product lifecycle.

Highest-signal resume keywords

Regulatory Affairs ExperienceRegulatory Submissions AuthoringFDA Regulatory KnowledgeRAC CertificationClass II/III Medical Device Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Classification EvaluationRegulatory Submission PreparationCompliance ActivitiesMarket Access Requirements IdentificationClinical Research ReportingProduct Registration MaintenanceRegulatory Filing SolutionsRegulatory Information GuidanceSubmission Development Communication

Soft Skills

Communication with Regulatory AuthoritiesProblem-SolvingCollaboration with R&D and Marketing Teams

Certifications & Qualifications

RAC CertificationAdvanced Degree in Regulatory Affairs

Industry Keywords

Software as a Medical Device (SaMD)FDAHighly Regulated IndustryClass II Medical DevicesClass III Medical DevicesRegulatory AssessmentsProduct Lifecycle ManagementRegulatory ChangesApproval PathwaysRegulatory Agencies Interaction

About the role

Key responsibilities & impact

Support R&D, Marketing, and Manufacturing teams with regulatory assessments of proposed changes or product transfers
Identify requirements and potential obstacles for market access and distribution
Assist in developing regulatory strategy and update strategy based on regulatory changes
Evaluate proposed products for regulatory classification and jurisdiction
Determine requirements and options for regulatory submissions, approval pathways, and compliance activities
Prepare and submit electronic and paper regulatory submissions
Provide regulatory information and guidance throughout the product lifecycle
Communicate with regulatory authorities during submission development and review
Evaluate pre-clinical, clinical, and manufacturing changes for regulatory filing solutions
Identify, monitor, and submit applicable reports or notifications during clinical research
Maintain current product registrations and process registration changes

Requirements

What you’ll need

Bachelor’s degree required; preferred in Engineering, Science, Regulatory Affairs, or a related technical field
Minimum of 2 years in a Regulatory Affairs role required
Experience in an FDA or highly regulated industry required
Experience supporting Software as a Medical Device (SaMD) products or software-enabled technologies within a regulated industry preferred
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
Previous experience with Class II/III medical devices preferred
Experience authoring regulatory submissions for product approval preferred
Experience interacting with regulatory agencies preferred

Benefits

Comp & perks

Hybrid work flexibility
Equal opportunity employment
0% travel requirement