Regulatory Affairs Manager – Vascular (on-site)

Abbott

Santa Clara, CA, United States
Base: $114,000.00 – $228,000.00; bonus/equity: not...
Onsite
Bachelor's degree in related field
Minimum 4 years regulated industry experience
Expertise in fda and international regulatory guidelines
This role involves developing new regulatory policies and providing strategic input to product lifecycle planning for Abbott Vascular

Job Summary

  • This role involves developing new regulatory policies and providing strategic input to product lifecycle planning for Abbott Vascular.
  • The successful candidate will prepare robust regulatory applications for the FDA and other international agencies to achieve organizational objectives.
  • Abbott offers comprehensive benefits including free medical coverage, a high employer contribution retirement plan, and tuition reimbursement.

Matching Summary

Match Score: 85

This role involves developing new regulatory policies and providing strategic input to product lifecycle planning for Abbott Vascular.

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

  • Bachelor's degree in related field
  • Minimum 4 years regulated industry experience
  • Expertise in FDA and international regulatory guidelines

Nice-to-have

  • RAC certification from Regulatory Affairs Professionals Society
  • Master's or Ph.D. in technical area
  • Experience with Class II and Class III medical devices

Key Requirements

  • Bachelor's Degree in related field
  • 4+ years experience in regulated industry
  • 2-5 years regulatory experience preferred
  • Knowledge of US (PMA, 510k) and EU MDR submissions

Work Rights

Not specified

Tailored Resume

Cover Letter