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
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.
Key responsibilities include developing regulatory strategies, preparing submissions, serving as an informational resource, and evaluating post-market incident reports.
The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, and 401(k) plan 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.
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, 80 hours holidays, paid time off
Skills & Requirements
Must-have
US and International regulatory strategy
product submissions and approvals
FDA, EU, ISO regulatory requirements
medical device regulatory experience
ISO Quality System regulations
Nice-to-have
customer success focus
innovation and collaboration
open and honest communication
integrity in actions
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 devices