Senior Ra Specialist

Stryker

Hybrid
Regulatory requirements assessment
Global submission activities support
Product lifecycle regulatory evaluation
Stryker is seeking a Senior Regulatory Affairs Specialist to support regulatory submissions and compliance for medical devices, ideally suited for candidates with 3-6 years of experience in regulatory affairs. The role is hybrid, emphasizing collaboration with cross-functional teams and a strong understanding of global regulatory frameworks

Job Summary

  • Supports assessment of regulatory requirements, stakeholder expectations, and emerging regulatory trends, and highlights potential impacts to regulatory teams.
  • Contributes to execution of regulatory strategies by supporting global, regional, and multi-country submission activities.
  • Ensures completeness, accuracy, and compliance of submission documentation in alignment with regulatory requirements.

Matching Summary

Match Score: 85

Stryker is seeking a Senior Regulatory Affairs Specialist to support regulatory submissions and compliance for medical devices, ideally suited for candidates with 3-6 years of experience in regulatory affairs. The role is hybrid, emphasizing collaboration with cross-functional teams and a strong understanding of global regulatory frameworks.

Skills & Requirements

Must-have

  • Regulatory requirements assessment
  • Global submission activities support
  • Product lifecycle regulatory evaluation
  • Regulatory dossier compilation and submission
  • Regulatory information management systems
  • Cross-functional team collaboration
  • Regulatory authority query response support

Nice-to-have

  • Process improvement focus
  • Adaptability in fast-paced environment
  • Accountability and ownership
  • Embraces feedback for improvement

Key Requirements

  • Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field
  • 3–6 years of experience in Regulatory Affairs
  • Experience with regulatory submissions, documentation, or publishing
  • Exposure to global regulatory frameworks

Work Rights

Not specified

Tailored Resume

Cover Letter