Senior Regulatory Affairs Specialist
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Portage • Missouri • United States
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Job Level
About the role
- Support Stryker’s Acute Care portfolio for the global market
- Maintain global market access by analyzing device modifications and emerging regulatory intelligence
- Identify global regulatory requirements to support new product development
- Enable global product sales in new markets by collaborating with global Stryker teams for registrations
- Evaluate device modifications to ensure global product compliance
- Support new product development in submitting registrations and renewals
- Analyze and advise on the impact of emerging regulatory intelligence
- Provide regulatory input and guidance to product development teams
- Prepare and submit regulatory submissions according to applicable requirements
Requirements
- Bachelor's degree
- 2+ years of experience in an FDA or highly regulated industry
- 2+ years of full-time work experience in Regulatory Affairs and/or Quality Systems
- Demonstrated ability to analyze and resolve non-routine regulatory issues using independent judgment
- Ability to manage multiple priorities and adapt to changing regulatory requirements
- Preferred: Bachelor's degree (B.S. or B.A.) in Science, Engineering, or a related discipline
- Experience supporting Class II and/or Class III medical devices
- Experience authoring or supporting FDA 510(k) submissions
- Prior experience interacting directly with regulatory agencies
- Experience authoring global regulatory submissions for product approval
- RAC certification or an advanced degree (e.g., Master’s in Regulatory Affairs)
Benefits
- Hybrid work flexibility
- 10% travel
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory AffairsQuality SystemsFDA 510(k) submissionsglobal regulatory submissionsdevice modificationsproduct complianceemerging regulatory intelligenceproduct developmentregistration submissionsrenewals
Soft Skills
analytical skillsindependent judgmentability to manage multiple prioritiesadaptability to changing requirements
Certifications
RAC certificationBachelor's degreeMaster’s in Regulatory Affairs