Senior Regulatory Affairs Specialist

Integer

Plymouth, MN, United States
Base: $113,025 - $165,770; bonus/equity: cash-base...
Us and international regulatory strategy
Product submissions and approvals
Fda, eu, iso, and other regulatory requirements
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, and participates on Product Development teams.
  • Our total rewards program includes base salary, cash-based incentive program, medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, holidays, and paid time off.

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 company matching

Skills & Requirements

Must-have

  • US and International regulatory strategy
  • product submissions and approvals
  • FDA, EU, ISO, and other regulatory requirements
  • medical device regulatory submission/approval experience
  • FDA Quality System regulations
  • ISO requirements

Nice-to-have

  • customer success focus
  • innovation and better solutions
  • collaboration and respect
  • open and honest communication
  • integrity and doing things right

Key Requirements

  • Bachelor’s degree in a related field
  • 7+ years of US and International medical device regulatory submission/approval experience
  • FDA, MDD, PMDA, TGA, and TPD experience
  • Knowledge of all applicable laws which regulate medical device manufacturers
  • Strong communication and technical writing skills

Work Rights

Not specified

Tailored Resume

Cover Letter