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 core values like Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity.
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: 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
post-market incident reports
regulatory status documents
Nice-to-have
customer success focus
collaboration and inclusion
open and honest communication
integrity in actions
Key Requirements
Bachelor’s degree in a related field
7+ years US and International medical device regulatory experience