Principal Regulatory Affairs Specialist – Vascular (on-site)

Abbott

Santa Clara, California, United States
Base: $100,000.00 – $200,000.00; bonus/equity: not...
Class iii devices
Pma/hde/ide submissions
Us and eu regulatory strategy
As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies

Job Summary

  • As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.
  • Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease.
  • You’ll also have access to: Career development with an international company where you can grow the career you dream of, an excellent retirement savings plan with high employer contribution, and tuition reimbursement.

Matching Summary

As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.

Salary

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

Skills & Requirements

Must-have

  • Class III devices
  • PMA/HDE/IDE submissions
  • US and EU regulatory strategy
  • FDA and international regulations
  • Product release process support

Nice-to-have

  • Strong attention to detail
  • Positive and cooperative communication
  • Ability to manage competing priorities
  • Risk identification and escalation

Key Requirements

  • Bachelor’s Degree in Scientific discipline
  • 5-7 years’ experience with Class III devices
  • Experience with PMA / IDE and international submissions
  • Working knowledge of QSR, ISO, and EN standards
  • Strong working knowledge of US, EU (EU MDR), and other international geographies

Work Rights

Not specified

Tailored Resume

Cover Letter