Assist with providing pre-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives for new and modified products. Assure that company’s products comply with United States and international medical device and import/export regulations. Correspond with governmental agencies and/or foreign distributors to determine product registration requirements and to provide evidence of compliance. Supports applicable regulations including Local, State, Federal and/or International requirements.
- Coordinate the completion and submission of regulatory product files to result in timely and efficient registration of products (for initial registration of new products and market extension for current products)
- Manage submissions such as US FDA Section 510(k) Notifications, EU CE Technical Documentation, and global product registrations.
- Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies
- Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.
- Must have knowledge of U.S, Canadian, European and other International in Medical Device regulations and standards.
- Must be able to work well in a team environment with individuals from diverse functional areas, as well as independently manage work.
- Must have proven analytical capabilities, solid understanding of manufacturing processes, change control, regulatory principles and regulatory trends.