Senior Regulatory Affairs Specialist

985fm.ca

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 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.
  • Key responsibilities include developing US and International regulatory strategies, preparing submissions, serving as an informational resource, and evaluating post-market incident reports.
  • The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, parental leave, and 401(k) with company matching.

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: comprehensive benefits package

Skills & Requirements

Must-have

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

Nice-to-have

  • customer success focus
  • innovation and collaboration
  • respectful interaction
  • 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 applicable laws regulating medical device manufacturers

Work Rights

Not specified

Tailored Resume

Cover Letter