Staff Regulatory Affairs Specialist

Stryker

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

Posted 10/5/2026full-timeRedmond • Washington • United StatesLead💰 $110,100 - $183,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a focus on medical devices, including experience in regulatory submissions, compliance activities, and product lifecycle management. Proficient in developing regulatory strategies and communicating effectively with stakeholders and regulatory authorities.

Highest-signal resume keywords

Regulatory Submissions ManagementRegulatory Affairs Certification (RAC)Experience With Class II And/Or Class III Medical DevicesRegulatory Strategy DevelopmentSoftware As A Medical Device (SaMD) Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AssessmentsRegulatory Filings PreparationProduct Classification EvaluationCompliance Activities SupportProduct Registration Maintenance

Soft Skills

Strong Communication Skills

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Medical DevicePharmaceuticalBiotechnologyRegulatory RequirementsProduct Lifecycle Management

About the role

Key responsibilities & impact

Support R&D, Marketing, and Manufacturing teams with regulatory assessments of proposed product changes, software updates, and product transfers
Support sustaining regulatory activities across a complex portfolio of products, ensuring ongoing compliance, product availability, and implementation of 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 regulatory requirements
Evaluate products for regulatory classification, jurisdiction, and applicable regulatory pathways
Prepare and submit regulatory filings in accordance with applicable regulatory requirements and agency guidelines
Provide regulatory guidance for product development, product lifecycle management, and planned product changes
Communicate and interact with regulatory authorities throughout submission development, review, and approval activities
Evaluate pre-clinical, clinical, manufacturing, and software changes and recommend appropriate regulatory filing strategies
Maintain product registrations and support required registration updates, reports, and notifications
Support the development of procedures, work instructions, and stakeholder training related to regulatory requirements and compliance activities

Requirements

What you’ll need

Bachelor’s degree required; preferred in Engineering, Science, Regulatory Affairs, or a related technical field
Minimum 4 years of experience in Regulatory Affairs within a medical device, pharmaceutical, biotechnology, or other highly regulated industry
Experience authoring and managing regulatory submissions, registrations, or product approvals
Experience with Class II and/or Class III medical devices preferred
Experience supporting Software as a Medical Device (SaMD) products preferred
Experience developing regulatory strategies for product development, lifecycle management, or product transfer activities preferred
Regulatory Affairs Certification (RAC) and/or master's degree in Regulatory Affairs or a related field preferred
Strong communication skills with the ability to explain regulatory requirements to technical and non-technical stakeholders

Benefits

Comp & perks

Hybrid work flexibility
Equal employment opportunity
10% travel percentage