Staff Regulatory Affairs Specialist, Mako and Enabling Technologies

Stryker

. Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities .

Posted 9/23/2026full-timeRemote • New Jersey • United StatesLead💰 $105,300 - $175,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing regulatory strategies for medical devices, including authoring FDA submissions and ensuring compliance with international regulations. Proven ability to mentor team members and lead interactions with regulatory authorities.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA SubmissionsRegulatory Affairs Certification (RAC)Medical Device ClassificationRegulatory Strategy Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory FilingsProduct ApprovalsQuality Documentation ReviewPreclinical Documentation ReviewClinical Documentation ReviewRegulatory Pathways EvaluationProduct Labeling ComplianceMarket Expansion StrategiesLifecycle ManagementSubmission Readiness

Soft Skills

MentoringCollaborationCommunication

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

FDA-Regulated IndustryClass II Medical DevicesClass III Medical DevicesInternational Regulatory RequirementsNotified BodiesAgency Communications

About the role

Key responsibilities & impact

Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities
Participate in product development teams to incorporate U.S., European, and international regulatory requirements throughout development phases
Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies
Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation for product approvals
Review quality, preclinical, and clinical documentation for submission readiness and regulatory compliance
Partner with global regulatory affiliates on registrations, market expansions, and post-market regulatory activities
Lead interactions with regulatory authorities and notified bodies, including responses, submissions, and agency communications
Review product labeling, marketing materials, and product claims for compliance
Mentor junior regulatory team members on regulatory processes and best practices

Requirements

What you’ll need

Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a related field
Minimum 4 years of experience in an FDA-regulated industry
Minimum 3 years of Regulatory Affairs experience
Experience preparing regulatory submissions for product approvals
Preferred: Regulatory Affairs Certification (RAC) and/or Master’s degree in Regulatory Affairs or a related field
Preferred: Experience supporting Class II and/or Class III medical devices
Preferred: Experience authoring FDA 510(k) submissions
Preferred: Experience interacting directly with regulatory agencies and notified bodies

Benefits

Comp & perks

Remote position
Preference for candidates located in the U.S. Eastern Time Zone
Travel Percentage: None