Senior Regulatory Affairs Specialist - Electrophysiology (on-site)

Abbott

Plymouth, Minnesota, United States
Base: $78,000.00 – $156,000.00; bonus/equity: not ...
Bachelor's degree in technical discipline
Minimum 2 years regulatory experience
Experience with fda and international regulations
Abbott is seeking a Senior Regulatory Affairs Specialist to lead regulatory approvals and resolve problems for their Electrophysiology business

Job Summary

  • Abbott is seeking a Senior Regulatory Affairs Specialist to lead regulatory approvals and resolve problems for their Electrophysiology business.
  • The role involves preparing robust applications, interfacing directly with the FDA, and ensuring global compliance with medical device regulations.
  • Employees enjoy comprehensive benefits including free medical coverage, high employer retirement contributions, and tuition reimbursement programs.

Matching Summary

Abbott is seeking a Senior Regulatory Affairs Specialist to lead regulatory approvals and resolve problems for their Electrophysiology business.

Salary

Base: $78,000.00 – $156,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor's degree in technical discipline
  • Minimum 2 years regulatory experience
  • Experience with FDA and international regulations
  • Medical device submission preparation
  • Cross-functional team collaboration

Nice-to-have

  • Advanced level degree preferred
  • Class II or Class III device experience
  • Mentoring and leadership capabilities
  • Matrixed business environment experience
  • Strong verbal and written communication

Key Requirements

  • Bachelor's Degree in biology, chemistry, microbiology, or related field
  • Minimum 2 years of relevant industrial regulatory experience
  • Proficiency with MS Office suite (Word, Excel, Outlook)

Work Rights

Not specified

Tailored Resume

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