Senior Regulatory Affairs Specialist - Medical Devices- Fda Focus

65

Base: $79,380 to $118,600 annually; bonus/equity: ...
5+ years regulatory affairs experience
Fda submission preparation expertise
510(k) application management
This role serves as the go-to expert for U.S. regulatory strategy and compliance within Novanta's Advanced Surgery business unit

Job Summary

  • This role serves as the go-to expert for U.S. regulatory strategy and compliance within Novanta's Advanced Surgery business unit.
  • The specialist is responsible for developing and executing FDA submission plans, including 510(k) applications, while acting as the primary liaison with regulatory authorities.
  • Novanta offers a competitive salary range of $79,380 to $118,600 annually along with a full range of medical, financial, and other benefits.

Matching Summary

This role serves as the go-to expert for U.S. regulatory strategy and compliance within Novanta's Advanced Surgery business unit.

Salary

Base: $79,380 to $118,600 annually; Bonus/Equity: Performance-based incentives may be eligible; Benefits: Full range of medical, financial, and other benefits provided

Skills & Requirements

Must-have

  • 5+ years regulatory affairs experience
  • FDA submission preparation expertise
  • 510(k) application management
  • Design control process compliance
  • Primary liaison with regulatory authorities

Nice-to-have

  • PMA application experience
  • Cross-functional team collaboration
  • Audit support and inspection readiness
  • Post-market surveillance management
  • Quality Management System improvement

Key Requirements

  • Bachelor's degree required
  • Advanced training in Regulatory Affairs for Medical Devices
  • Willingness to travel up to 10%

Work Rights

Not specified

Tailored Resume

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