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 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

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.
  • Key responsibilities include developing regulatory strategies, preparing submissions, serving as an informational resource, and evaluating post-market incident reports.
  • The company offers a comprehensive total rewards program including base salary, cash-based incentive, medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with matching, 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.

Salary

Base: $113,025 - $165,770; Bonus/Equity: Cash-based incentive program; Benefits: Comprehensive benefits package with immediate eligibility

Skills & Requirements

Must-have

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

Nice-to-have

  • customer success focus
  • innovation and collaboration
  • respectful interaction
  • open and honest communication
  • integrity in actions

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 FDA Quality System regulations and ISO requirements
  • Ability to work through difficult issues with suppliers and customers

Work Rights

Not specified

Tailored Resume

Cover Letter