About the Role
Role details below.
Responsibilities
- Lead Regulatory Associates or Specialists in addition to work as an individual contributor
- Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements
- Be involved in EU submissions
- Represent RA as core member to drive innovation on Tech. Dev. Projects and follow through to market release
- Develop Regulatory Strategies for new or modified products and prepare project plans & budgets
- Monitor and provide management with impact of changes in the Regulatory environment
- Communicate with regulatory agencies on administrative and routine matters
- Communicate with regulatory agencies on pre-clinical, pre-submission, and submission discussions under the direction of management
- Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators
- Support Design Control process
- Prepare Rational to file documentation for modifications to devices when appropriate
- Participate in FDA & other notified body Inspections
- Author and/or review regulatory procedures and update as necessary
- Review change control documents and ascertain Regulatory impact for external and int
Work Arrangement
Remote (Worldwide)