Senior Regulatory Affairs Specialist

724842

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.
  • The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through common values like customer focus, innovation, collaboration, inclusion, candor, and integrity.
  • The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility (medical, dental, vision, disability, life insurance, adoption benefits), parental leave, 401(k) with company 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 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, and other regulatory requirements
  • medical device regulatory submission/approval experience
  • FDA Quality System regulations and ISO requirements

Nice-to-have

  • common set of values
  • culture that unifies
  • embraces uniqueness
  • focus on customers' success
  • create better solutions
  • interact respectfully
  • open and honest

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
  • Ability to work through difficult issues with suppliers and customers
  • Strong communication and technical writing skills
  • Skill in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000
  • Skill in working with computers and experience with spreadsheet and word-processing software

Work Rights

Not specified

Tailored Resume

Cover Letter