Senior Regulatory Affairs Specialist

Stryker

. Develop and implement regulatory strategies and submission plans based on product classification, market requirements, approval pathways, and applicable regulations .

Posted 10/19/2026full-timePortage • Michigan • United StatesSenior💰 $83,300 - $138,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing regulatory strategies, preparing regulatory documentation, and ensuring post-market compliance within the medical device industry. Proficient in collaborating with cross-functional teams and interacting with regulatory authorities to support product development and commercialization.

Highest-signal resume keywords

Regulatory Affairs ExperienceRegulatory Submissions PreparationPost-Market Compliance ManagementRegulatory Strategy DevelopmentRegulatory Inspections Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation PreparationProduct RegistrationRegulatory Impact EvaluationCompliance Requirements AnalysisSafety ReportingProduct Recall ManagementRegulatory Intelligence MonitoringAdvertising Review for Regulatory AlignmentStandard Operating Procedures DevelopmentTraining Stakeholders

Soft Skills

CollaborationCommunicationProblem-Solving

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Medical Device IndustryRegulated IndustryMarket Access ConsiderationsProduct Lifecycle ManagementRegulatory Authorities Interaction

About the role

Key responsibilities & impact

Develop and implement regulatory strategies and submission plans based on product classification, market requirements, approval pathways, and applicable regulations
Prepare and submit regulatory documentation, including product registrations, annual licenses, listings, supplemental dossiers, and notifiable changes
Evaluate product and manufacturing changes for regulatory impact and recommend submission, approval, and compliance requirements throughout the product lifecycle
Maintain post-market regulatory compliance by supporting safety reporting, product recalls, post-market commitments, required reports, and communications with regulatory authorities
Review advertising, promotional materials, product labeling, and instructions for use for regulatory alignment
Monitor regulatory intelligence and assess emerging requirements, risks, and market access considerations
Partner with Product Development, Quality, Marketing, and other stakeholders on product development, commercialization, and lifecycle activities
Support regulatory inspections and audits, develop regulatory procedures and standard operating procedures, and train stakeholders

Requirements

What you’ll need

Bachelor’s degree in Engineering, Science, Life Sciences, or a related discipline
Minimum 2 years of experience in Regulatory Affairs or a related regulatory discipline within a regulated industry
Experience preparing, coordinating, or executing regulatory submissions and related documentation
Experience interpreting and applying regulatory requirements to product development, commercialization, or post-market activities
Preferred: Master's degree in Regulatory Science or Regulatory Affairs Certification (RAC)
Preferred: Experience in the medical device industry
Preferred: Experience supporting product registrations, regulatory submissions, product changes, or post-market regulatory activities across multiple markets
Preferred: Experience interacting with regulatory authorities or supporting regulatory inspections and audits
Ability to work onsite two to three days per week in Portage, Michigan
Willingness to travel 10%

Benefits

Comp & perks

Hybrid work flexibility
Equal opportunity employment
Pay transparency and protection against pay discrimination