Regulatory Affairs Specialist Ii – Electrophysiology (on-site)

Abbott

Plymouth, Minnesota, United States
Base: $61,300.00 – $122,700.00; bonus/equity: not ...
On-site
Preparation of regulatory submissions for electrophysiology devices
Review and approve engineering change orders
Knowledge of fda and international medical device regulations
Abbott is seeking a Regulatory Affairs Specialist II for their Electrophysiology division in Plymouth, Minnesota. The role involves preparing regulatory submissions for medical devices, ensuring compliance with regulatory standards, and collaborating with cross-functional teams

Job Summary

  • Abbott is seeking a Regulatory Affairs Specialist II to join the Electrophysiology team on-site in Plymouth, MN.
  • The role involves preparing regulatory submissions, reviewing engineering change orders, and ensuring compliance with FDA and global standards.
  • Employees enjoy benefits including free medical coverage options, high employer retirement contributions, and tuition reimbursement programs.

Matching Summary

Match Score: 85

Abbott is seeking a Regulatory Affairs Specialist II for their Electrophysiology division in Plymouth, Minnesota. The role involves preparing regulatory submissions for medical devices, ensuring compliance with regulatory standards, and collaborating with cross-functional teams.

Salary

Base: $61,300.00 – $122,700.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Preparation of regulatory submissions for Electrophysiology devices
  • Review and approve engineering change orders
  • Knowledge of FDA and international medical device regulations

Nice-to-have

  • Experience with capital equipment software and firmware
  • Strong verbal and written communication skills
  • Ability to work in a fast-paced matrixed environment

Key Requirements

  • Bachelor's degree required
  • 2-3 years experience in regulated industry
  • Master's degree in Regulatory Affairs preferred
  • RAC certification is a plus

Work Rights

Not specified

Tailored Resume

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