Senior Regulatory Affairs Specialist

486

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 Accountabilities include developing regulatory strategies, preparing submissions, serving as an informational resource, evaluating post-market incidents, and assisting with recalls.
  • The total rewards program includes base salary, a 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: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, 80 hours holidays, paid time off

Skills & Requirements

Must-have

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

Nice-to-have

  • common set of values
  • customer success focus
  • innovation and collaboration
  • inclusion and respect
  • open and honest communication
  • integrity and doing things right

Key Requirements

  • Bachelor’s degree in a related field
  • 7+ years US and International medical device regulatory submission/approval experience
  • FDA, MDD, PMDA, TGA, TPD experience
  • Knowledge of FDA Quality System regulations and ISO requirements
  • Knowledge of applicable laws regulating medical device manufacturers
  • Skill in working with computers and spreadsheet/word-processing software

Work Rights

Not specified

Tailored Resume

Cover Letter