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 and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards
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 and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.
Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.
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 and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.
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 matching, 80 hours holidays, paid time off
Skills & Requirements
Must-have
US and International regulatory strategy
Product submission and approval
FDA, EU, ISO compliance
Medical device regulatory experience
Technical writing skills
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 of US and International medical device regulatory submission/approval experience
Knowledge of FDA Quality System regulations and ISO requirements
Ability to work through difficult issues with suppliers and customers