Senior Principal Regulatory Affairs Specialist

Baltgroup

Irvine, United States
Base: $170,000 - $200,000 usd; bonus/equity: not s...
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Global regulatory strategies
Us and international submissions
Regulatory agencies interaction
** Baltgroup is seeking a Senior Principal Regulatory Affairs Specialist to oversee regulatory approvals for medical devices, emphasizing strategic guidance and cross-functional collaboration. The ideal candidate should possess extensive regulatory experience, particularly with high-risk medical devices, and be skilled in project management and compliance documentation. **

Job Summary

  • The Sr. Principal Regulatory Affairs Specialist is responsible for completing and maintaining regulatory approvals/clearances for new and modified medical devices, license renewals, and annual registrations.
  • Develop and implement global regulatory strategies for complex, high-risk medical devices including contingency plans and represent Regulatory Affairs on project teams.
  • Balt is a rapidly growing pioneer in an exceptional field, proud of its mission, people, and the incredible work accomplished together to empower physicians to save lives.

Matching Summary

Match Score: 75

** Baltgroup is seeking a Senior Principal Regulatory Affairs Specialist to oversee regulatory approvals for medical devices, emphasizing strategic guidance and cross-functional collaboration. The ideal candidate should possess extensive regulatory experience, particularly with high-risk medical devices, and be skilled in project management and compliance documentation. **

Salary

Base: $170,000 - $200,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • global regulatory strategies
  • US and international submissions
  • regulatory agencies interaction
  • device labeling compliance
  • advertising and promotion review

Nice-to-have

  • strategic thinking and creativity
  • works well under pressure
  • multicultural community

Key Requirements

  • Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications experience
  • Nine (9) + years of professional regulatory experience
  • Documented experience in preparation of US and EU submissions
  • Experience interfacing with relevant regulatory authorities
  • Minimum BA/BS degree or higher in a scientific or technical discipline

Work Rights

Not specified

Tailored Resume

Cover Letter