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Stryker Corporation is seeking a Senior Regulatory Affairs Specialist to support regulatory strategies and submission activities in a hybrid work environment. The role involves coordinating regulatory documentation, collaborating with cross-functional teams, and ensuring compliance with various regulatory frameworks.
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Job Summary
The role involves supporting the assessment of regulatory requirements and emerging trends to highlight potential impacts on teams.
Candidates will coordinate the preparation, compilation, and submission of regulatory dossiers including FDA 510(k) and EU MDR Technical Files.
The position requires maintaining audit-ready documentation and collaborating with cross-functional teams to ensure product compliance.
Matching Summary
Match Score: 75
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Stryker Corporation is seeking a Senior Regulatory Affairs Specialist to support regulatory strategies and submission activities in a hybrid work environment. The role involves coordinating regulatory documentation, collaborating with cross-functional teams, and ensuring compliance with various regulatory frameworks.
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Skills & Requirements
Must-have
Bachelor's degree in Engineering or Life Sciences
3-6 years Regulatory Affairs experience
FDA and EU MDR regulatory framework knowledge
Nice-to-have
Advanced degree preferred
Experience with global regulatory submissions
Process improvement mindset
Key Requirements
Bachelor's degree in Engineering, Life Sciences, or Pharmacy
3–6 years of experience in Regulatory Affairs
Knowledge of FDA, EU MDR, TGA, NMPA, PMDA, CDSCO frameworks