Senior Regulatory Affairs Specialist

CyberJobsHub

Plymouth, MN, United States
Base: $113,025 - $165,770; bonus/equity: cash-base...
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Us and international regulatory submissions
Fda quality system regulations knowledge
Iso requirements knowledge
** Integer is seeking a Senior Regulatory Affairs Specialist to oversee regulatory activities for medical devices, ensuring compliance with FDA, EU, and other international standards. The ideal candidate will have over seven years of experience in regulatory submissions and approvals, along with strong communication skills. **

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.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including base salary, cash-based incentives, comprehensive benefits, and 401(k) with company matching.
  • By living according to a common set of values, we create a culture that unifies, embraces uniqueness, and positions Integer for long-term success.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Regulatory Affairs Specialist to oversee regulatory activities for medical devices, ensuring compliance with FDA, EU, and other international standards. The ideal candidate will have over seven years of experience in regulatory submissions and approvals, along with strong communication skills. **

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 match, paid time off

Skills & Requirements

Must-have

  • US and International regulatory submissions
  • FDA Quality System regulations knowledge
  • ISO requirements knowledge
  • Regulatory strategy development
  • Medical device regulatory compliance
  • Technical writing skills
  • Supplier and customer relations

Nice-to-have

  • Collaboration and teamwork
  • Innovation mindset
  • Customer focus
  • Respectful interaction
  • Open and honest communication
  • Integrity in work
  • Experience with FDA inspections

Key Requirements

  • Bachelor’s degree in a related field
  • 7+ years US and International medical device regulatory experience
  • Experience with FDA, MDD, PMDA, TGA, and TPD
  • Knowledge of applicable medical device laws
  • Ability to work through difficult issues with suppliers and customers

Work Rights

Not specified

Tailored Resume

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