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.
Key Accountabilities and Responsibilities
1. Adheres to Integer's Core Beliefs and all safety and quality requirements.
2. Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
3. Provides strategic input. Participates on Product Development teams, providing a high level of experience in regulatory, strategy, timelines, and direction.
4. Prepares US and International submissions and work with government agencies and/or distributors to obtain product approval/clearance.
5. Serves as informational resource for all departments, assisting in keeping company informed of US and International regulatory requirements. Ensures relevant International, ISO and FDA Export requirements are met, as required and ensures accuracy of submission information.
6. Initiates FDA export approval requires and product release authorizations.
7. Reviews ECO's and assess effect of product changes on US and International regulatory strategy and submissions per standard procedures.
8. Evaluates post-market incident reports and determine MDR requirements.
9. Assists with recall/retrieval documentation and other activities.
10. Develops and maintains regulatory status documents and submission procedures.
11. Identifies, investigates, evaluates and implements as appropriate new methodologies associated with product quality and quality systems.
12. Performs other functions as required.
Minimum Education: Bachelor's degree in a related field.
Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA, and TPD experience.
Specialized Knowledge: Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of all applicable laws which regulate medical device manufacturers. Ability to work through difficult issues with suppliers and customers.
Special Skills: Strong communication and technical writing skills. Skill in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000.