Iso 9000 and fda quality system regulations knowledge
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 US and International medical device regulatory submission and approval experience including specific knowledge of FDA, MDD, PMDA, TGA, and TPD requirements.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, adoption benefits, and 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 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 expertise
ISO 9000 and FDA Quality System regulations knowledge
Nice-to-have
Strong technical writing and communication skills
Experience with supplier and customer relations
Ability to work through difficult issues collaboratively
Key Requirements
Bachelor's degree in a related field
7+ years of US and International medical device regulatory experience
Knowledge of applicable laws regulating medical device manufacturers