The Greatbatch Global Regulatory team is looking for a Regulatory Affairs Specialist who will 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.
- Participates on Product Development teams, providing experience in regulatory, strategy, timelines, and direction.
- Prepares US and International submissions and works with government agencies and/or distributors to obtain product approval/clearance.
- Serves as informational resource assisting in keeping company informed of regulatory requirements.
- Ensures International, ISO and FDA Export requirements are met and ensures accuracy of submission information.
- Initiates FDA export approval requires and product release authorizations.
- Reviews ECO’s and assess effect of product changes on regulatory strategy and submissions.
- Evaluates post-market incident reports and determines MDR requirements.
- Assists with recall/retrieval documentation and other activities.
- Develops and maintains regulatory status documents and submission procedures.
Minimum Education: Bachelor’s degree in a related field.
Minimum Experience: 4+ 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; Experience with FDA inspections, ISO 9000.
Special Skills: Strong communication and technical writing skills; Knowledge of precision measurement, auditing, training, supplier/customer relations; Ability to work through difficult issues with suppliers and customers; Strong Microsoft Office skills.
Greatbatch - 19 months ago