The primary purpose of this job is to strategically plan and execute regulatory activities to obtain and maintain approvals in the United States and International markets
Job Summary
The primary purpose of this job is to strategically plan and execute regulatory activities to obtain and maintain approvals in the United States and International markets.
Candidates must possess at least 7 years of experience with US and International medical device regulatory submissions including FDA, MDD, PMDA, TGA, and TPD.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching contributions.
Matching Summary
The primary purpose of this job is to strategically plan and execute regulatory activities to obtain and maintain approvals in the United States and International markets.
Salary
Base: $113,025 - $165,770; Bonus/Equity: Cash-based incentive program supporting pay-for-performance philosophy; Benefits: Comprehensive package including medical, dental, vision, disability, life insurance, adoption benefits, parental leave, and 401(k) with matching.
Skills & Requirements
Must-have
7+ years medical device regulatory experience
FDA MDD PMDA TGA TPD submission knowledge
ISO 9000 and FDA Quality System regulations
Strategic planning for product approvals
Technical writing for government submissions
Nice-to-have
Strong supplier and customer relations skills
Experience with FDA inspections and auditing
Ability to work through difficult issues
Collaborative team player mindset
Open and honest communication style
Key Requirements
Bachelor's degree in a related field
7+ years of US and International medical device regulatory submission/approval experience
Knowledge of FDA Quality System regulations and ISO requirements