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.
Candidates must possess a minimum of 7 years of experience in US and International medical device regulatory submissions including FDA, MDD, PMDA, TGA, and TPD.
The company offers a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate eligibility for a 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: Comprehensive package including medical, dental, vision, 401(k) match
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 US and International approvals
Post-market incident evaluation and MDR requirements
Nice-to-have
Strong communication and technical writing skills
Experience with supplier and customer relations
Ability to work through difficult issues collaboratively
Proficiency in spreadsheet and word-processing software
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