Regulatory Affairs Specialist

ZOLL

Base: $85,000.00 to $123,000.00; bonus/equity: eli...
Fully remote
Bachelor's degree in science or engineering
Regulatory affairs experience in medical device industry
Experience with electro-mechanical products
ZOLL is seeking a Regulatory Affairs Specialist to develop and implement regulatory strategies for their resuscitation products and features. The ideal candidate should have at least one year of experience in regulatory affairs, preferably within the medical device industry, and possess a relevant bachelor's degree

Job Summary

  • The role involves developing and implementing regional regulatory strategies for new and sustaining ZOLL Resuscitation products to ensure device approval.
  • Candidates will author and prepare critical submittals including IDEs, 510(k), PMAs, and Technical Files while collaborating with cross-functional NPI project teams.
  • ZOLL offers a competitive salary range of $85,000 to $123,000 with eligibility for an annual bonus and comprehensive benefits.

Matching Summary

Match Score: 85

ZOLL is seeking a Regulatory Affairs Specialist to develop and implement regulatory strategies for their resuscitation products and features. The ideal candidate should have at least one year of experience in regulatory affairs, preferably within the medical device industry, and possess a relevant bachelor's degree.

Salary

Base: $85,000.00 to $123,000.00; Bonus/Equity: Eligible for annual bonus; Benefits: Comprehensive benefits plans available

Skills & Requirements

Must-have

  • Bachelor's Degree in Science or Engineering
  • Regulatory Affairs experience in medical device industry
  • Experience with electro-mechanical products
  • Authoring IDEs, 510(k), PMAs, Technical Files
  • Risk assessment and regulatory compliance

Nice-to-have

  • Advanced Degree preferred
  • Experience in electro cardiology or defibrillation space
  • Strong written and verbal communication skills
  • Ability to create action plans and project deliverables
  • Support culture of continuous improvement

Key Requirements

  • Bachelor's Degree in Relevant Science/Engineering
  • 1+ Years Regulatory Affairs Experience
  • Proven experience in electro-mechanical products
  • Advanced Degree preferred

Work Rights

Not specified

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