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Senior Regulatory Affairs Specialist-Medical Devices

Salary undisclosed

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Job Title: Senior Regulatory Affairs Specialist-Medical Devices Location: Irvine, CA 92606

Duration: 12 Months

Summary

The Senior Regulatory Affairs Specialist will manage and maintain regulatory approvals and clearances for assigned products, ensuring compliance with global regulations.

Key Responsibilities

  • Create and track regulatory submissions, ensuring alignment with global operating plans.
  • Provide guidance on OUS regulatory strategies and assess impacts of global regulations.
  • Represent the OUS regulatory function in product development and manufacturing teams.
  • Advise on registration requirements for new and renewing products, and improve processes based on feedback.
  • Perform other duties as assigned by leadership.

Additional Skills

  • Strong knowledge of global medical device regulations (Class II and III).
  • Proficient in Microsoft Office Suite (Word, PowerPoint, Excel).
  • Excellent written and verbal communication skills.
  • Strong problem-solving and analytical abilities.
  • Attention to detail and ability to manage competing priorities in a fast-paced environment.
  • Ability to work collaboratively across departments.

Education And Experience

  • Bachelor's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
  • 5-7 years of relevant experience.

If interested to apply! Please contact me at [email protected] or +1-732-653-9472