Staff Regulatory Affairs Specialist - Pleasanton, Ca

Calyxo, Inc.

Pleasanton, CA, United States
On-site
Deep fda regulatory expertise
Experience with 510(k) submissions
Leading complex international filings
The company is seeking a senior individual contributor to drive complex U.S. and international regulatory submissions for kidney stone treatment devices

Job Summary

  • The company is seeking a senior individual contributor to drive complex U.S. and international regulatory submissions for kidney stone treatment devices.
  • This role involves acting as the primary liaison with the FDA and global regulatory bodies while leading audits and inspections.
  • The successful candidate will provide expert regulatory input into product development, ensuring compliance is built into the design process from concept through commercialization.

Matching Summary

The company is seeking a senior individual contributor to drive complex U.S. and international regulatory submissions for kidney stone treatment devices.

Skills & Requirements

Must-have

  • Deep FDA regulatory expertise
  • Experience with 510(k) submissions
  • Leading complex international filings
  • QMS compliance knowledge
  • FDA audit and inspection liaison

Nice-to-have

  • Mentoring junior team members
  • Proactive collaborative mindset
  • Strategic product development input
  • Claims matrix ownership experience

Key Requirements

  • Senior level regulatory professional
  • Advanced command of global regulatory landscapes
  • Independent ability to drive complex submissions

Work Rights

Not specified

Tailored Resume

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