Regulatory Affairs Manager - Vascular (on-site)

AbbVie

Santa Clara, California, United States
Base: $114,000.00 – $228,000.00; bonus/equity: not...
Regulatory submissions preparation
Fda and international regulatory compliance
Product lifecycle regulatory planning
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease

Job Summary

  • Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease.
  • This Regulatory Affairs Manager position is an on-site opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division.
  • Employees can qualify for free medical coverage, excellent retirement savings plans, tuition reimbursement, and other educational benefits.

Matching Summary

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease.

Salary

Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Regulatory submissions preparation
  • FDA and international regulatory compliance
  • Product lifecycle regulatory planning
  • Cross-functional team collaboration
  • Regulatory risk evaluation
  • On-site work in Santa Clara

Nice-to-have

  • Mentorship and leadership skills
  • Experience with 510(k)/PMA submissions
  • Knowledge of Class II and III devices
  • Strong attention to detail
  • Ability to manage multiple priorities
  • Experience with post-approval changes

Key Requirements

  • Bachelor's degree or equivalent experience
  • Minimum 4 years regulated industry experience
  • 2-5 years regulatory experience preferred
  • Certification such as RAC is a plus
  • Experience with FDA 510(k)/PMA and international submissions
  • Ability to communicate and negotiate regulatory matters

Work Rights

Not specified

Tailored Resume

Cover Letter