Senior Regulatory Affairs Specialist

809

Plymouth, MN, United States
Base: $113,025 - $165,770; bonus/equity: cash-base...
Us and international regulatory strategy
Product submission and approval
Fda, eu, iso compliance
The primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards

Job Summary

  • The primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.
  • Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.

Matching Summary

The primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.

Salary

Base: $113,025 - $165,770; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with match, 80 hours holidays, PTO

Skills & Requirements

Must-have

  • US and International regulatory strategy
  • product submission and approval
  • FDA, EU, ISO compliance
  • medical device regulatory submissions
  • technical writing skills

Nice-to-have

  • common set of values
  • customer success focus
  • collaboration and respect
  • open and honest communication
  • integrity in actions

Key Requirements

  • Bachelor’s degree in a related field
  • 7+ years US and International medical device regulatory experience
  • FDA, MDD, PMDA, TGA, TPD experience
  • Knowledge of FDA Quality System regulations
  • Knowledge of ISO requirements
  • Knowledge of applicable medical device laws

Work Rights

Not specified

Tailored Resume

Cover Letter