Principal Regulatory Affairs Program Specialist

ZOLL

Base: $130,000.00 to $144,000.00; bonus/equity: el...
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8+ years regulatory affairs experience
3+ years electro-mechanical software products
Submission writing experience required
** ZOLL is seeking a Principal Regulatory Affairs Program Specialist to support the development and commercialization of medical devices aimed at improving patient outcomes. The role involves collaboration with cross-functional teams to develop regulatory strategies, ensuring compliance with global regulations while providing clear guidance on product documentation and change requests. **

Job Summary

  • The Principal Regulatory Affairs Program Specialist acts as the technical liaison between project teams and Regulatory Affairs to shape global regulatory pathways.
  • This role requires developing and managing regulatory strategies for new and sustaining products that result in device approval across global markets.
  • ZOLL offers a competitive annual salary ranging from $130,000.00 to $144,000.00 with eligibility for an annual bonus and comprehensive benefits.

Matching Summary

Match Score: 75

** ZOLL is seeking a Principal Regulatory Affairs Program Specialist to support the development and commercialization of medical devices aimed at improving patient outcomes. The role involves collaboration with cross-functional teams to develop regulatory strategies, ensuring compliance with global regulations while providing clear guidance on product documentation and change requests. **

Salary

Base: $130,000.00 to $144,000.00; Bonus/Equity: Eligible for annual bonus; Benefits: Comprehensive plans available

Skills & Requirements

Must-have

  • 8+ years regulatory affairs experience
  • 3+ years electro-mechanical software products
  • Submission writing experience required
  • Bachelor's degree in technical discipline
  • Global regulatory strategy development

Nice-to-have

  • Master's degree in Regulatory Affairs
  • Regulatory Affairs Certification preferred
  • Electrocardiology or defibrillation space experience
  • Leadership skills in team setting
  • Continuous improvement culture promotion

Key Requirements

  • Bachelor's Degree in Science or Engineering
  • 8+ years regulatory affairs experience
  • 3+ years electro-mechanical/software medical products
  • Submission writing experience
  • Advanced degree or RA certification (preferred)

Work Rights

Not specified

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