Principal Regulatory Affairs Specialist – Vascular (on-site)

Abbott

Santa Clara, CA, US
Base: $100,000.00 – $200,000.00; bonus/equity: not...
Bachelor's degree in scientific discipline
Experience with class iii device submissions
Knowledge of 21 cfr 820 and iso 13485
The role involves developing global regulatory strategies for new and modified Class III vascular devices

Job Summary

  • The role involves developing global regulatory strategies for new and modified Class III vascular devices.
  • Candidates will act as a liaison between the company and regulatory agencies like the FDA and Notified Bodies.
  • Abbott offers comprehensive benefits including free medical coverage, high employer retirement contributions, and tuition reimbursement.

Matching Summary

The role involves developing global regulatory strategies for new and modified Class III vascular devices.

Salary

Base: $100,000.00 – $200,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor's Degree in Scientific discipline
  • Experience with Class III device submissions
  • Knowledge of 21 CFR 820 and ISO 13485
  • Expertise in FDA and international regulatory requirements
  • Ability to manage multiple competing priorities

Nice-to-have

  • Strong analytical and problem-solving skills
  • Excellent written and verbal communication
  • Collaborative team player with minimal oversight
  • Attention to detail in complex projects

Key Requirements

  • Bachelor's Degree in Chemistry, Life Sciences, or Biology
  • 5-7 years experience in regulated industry
  • Experience with PMA/IDE and international submissions
  • RAC certification is a plus
  • Working knowledge of EU MDR and US QSR

Work Rights

Not specified

Tailored Resume

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