Sr. Regulatory Affairs Specialist-Denver, CO Position is responsible for securing U.S. and international regulatory clearance or approval for Spine products/accessories, including developing regulatory submissions and documentation. Incumbent is the regulatory interface during the product commercialization process and throughout the entire product life cycle including post-market surveillance. 1. Participate as a core team member on cross-functional new product development teams, providing regulatory direction and input. 2. Develop global regulatory strategies for products in collaboration with other regulatory team members and cross-functional business partners; execute strategies to secure regulatory approvals. 3. Liaise with regulatory authorities as needed in securing global regulatory approvals. 4. Identify regulatory requirements related to specific product development and testing; review and approve technical documentation in support of global regulatory strategies, e.g., test protocols and reports, validation documents, etc. Assist in the development and implementation of required post-market surveillance. 5. Author regulatory submissions/documents, including but not limited to: o Premarket notifications (510(k)) o Premarket Applications (PMA) – original or supplements o Humanitarian Device Exemptions (HDE) o Investigational Device Exemptions (IDE) o Design Dossiers o Renewals o Technical Files o Change Notifications o Master Files o Letters to File 6. Create, update, and maintain regulatory data. 7. Assist in creation of product labeling and instructions for use [package inserts] by collaborating with cross-functional business partners. 8. Plan and participate in industry sponsored workgroups. 9. Review and approve marketing literature and other items for compliance with relevant regulatory requirements. 10. Review Engineering Change Requests (ECRs) for global regulatory impact. 11. Author, review, and/or approve internal operating procedures related to regulatory affairs. 12. Perform related duties as required Job Requirements: • Bachelor’s or higher degree in clinical/science field, or similar work experience. • 5-8 years’ experience in device or pharmaceutical regulatory affairs is desired. • Requires the ability to work with a variety of levels both within and outside the organization. • Working knowledge of FDA and regulations and how to interpret and monitor them. • Knowledge of domestic/international medical device regulations • Strong attention to detail • Strong computer skills, including word • processing, spreadsheet and data programs • Good oral and written communication skills
Posted on: Thu, 20 Mar 2014 18:27:37 +0000
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