7+ years us and international medical device regulatory experience
Knowledge of fda, mdd, pmda, tga, and tpd regulations
Experience with iso 9000 and quality system regulations
The primary purpose of this job is to strategically plan, execute, and provide oversight to regulatory activities necessary to obtain and maintain 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 approvals within the United States and International markets.
Candidates must possess a Bachelor's degree and at least 7 years of specific experience in US and International medical device regulatory submission and approval processes.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, 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 approvals within the United States and International markets.
Salary
Base: $113,025 - $165,770; Bonus/Equity: Cash-based incentive program; Benefits: Comprehensive package with 401(k) match
Skills & Requirements
Must-have
7+ years US and International medical device regulatory experience
Knowledge of FDA, MDD, PMDA, TGA, and TPD regulations
Experience with ISO 9000 and Quality System regulations
Ability to prepare US and International product submissions
Strong technical writing and communication skills
Nice-to-have
Strategic input on product development teams
Experience managing supplier and customer relations
Skill in auditing and training activities
Ability to work through difficult compliance issues
Key Requirements
Bachelor's degree in a related field
7+ years of US and International medical device regulatory experience
Knowledge of FDA, MDD, PMDA, TGA, and TPD requirements
U.S. Applicant status (Equal Opportunity Employer statement)