Senior Regulatory Affairs Specialist – Vascular (on-site)

Abbott

Santa Clara, CA, US
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Regulatory submissions preparation
Regulatory compliance monitoring
Cross-functional collaboration
Abbott is a global healthcare leader that helps people live more fully at all stages of life with a diverse portfolio of life-changing technologies

Job Summary

  • Abbott is a global healthcare leader that helps people live more fully at all stages of life with a diverse portfolio of life-changing technologies.
  • The Senior Regulatory Affairs Specialist role supports regulatory processes for Abbott Vascular’s innovative minimally invasive vascular products at on-site locations in Santa Clara or Temecula, CA.
  • Abbott offers career development, excellent benefits including free medical coverage, retirement savings plans, tuition reimbursement, and is recognized globally as a great place to work.

Matching Summary

Abbott is a global healthcare leader that helps people live more fully at all stages of life with a diverse portfolio of life-changing technologies.

Salary

Base: $90,000.00 – $180,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings, tuition reimbursement

Skills & Requirements

Must-have

  • Regulatory submissions preparation
  • Regulatory compliance monitoring
  • Cross-functional collaboration
  • Regulatory strategy development
  • Documentation review and submission
  • Product lifecycle regulatory support

Nice-to-have

  • Experience with US FDA and EU Notified Body
  • Knowledge of international regulatory markets
  • Ability to work in matrixed environment
  • Critical thinking and multitasking skills
  • Experience in Medical Device industry
  • Strong organizational skills

Key Requirements

  • Bachelor’s degree or equivalent experience
  • 3-4 years regulated industry experience
  • 2-3 years regulatory experience preferred
  • Effective verbal and written communication
  • Experience with US 510(k) and PMA submissions
  • Experience with EU Technical Documentation
  • Certification such as RAC is a plus

Work Rights

Not specified

Tailored Resume

Cover Letter