Senior Regulatory Affairs Specialist

Integer

Plymouth, MN, United States
Base: $113,025 - $165,770; bonus/equity: cash-base...
Us and international regulatory strategies
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.
  • Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.

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 strategies
  • 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

  • common set of values
  • focus on customers' success
  • create better solutions
  • interact with others respectfully
  • open and honest with one another

Key Requirements

  • Bachelor’s degree in a related field
  • 7+ years of US and International medical device regulatory submission/approval experience
  • Knowledge of all applicable laws which regulate medical device manufacturers
  • Strong communication and technical writing skills
  • Skill in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000
  • Experience with spreadsheet and word-processing software

Work Rights

Not specified

Tailored Resume

Cover Letter