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Manager of Regulatory Affairs
| PostId | 2e22c8d8-1df2-4aeb-a894-5b3804240100 |
| Posted Date: | 4/26/2010 |
| Job Category: | Regulatory |
| Salary Range: | DOE |
| Location: | Bay Area (Peninsula) |
| Description: | Position Title: Manager of Regulatory Affairs Reports To: VP of RA/CA/QA Location: Peninsula Company: Private Duties & Responsibilities: The Regulatory Affairs Manager will be responsible for: • Developing and implementing regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards • Ensuring compliance with global regulations and regulating agencies • Interpret the intent of regulations and policies and provide such information to project teams and management • Instilling and driving a regulatory culture across the organization • Establishing and supporting policies and standards for the measurement of new products • Developing IDE, 510K, and PMA submissions for class II and III medical devices • Conducting submission negotiations with the FDA as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval • Maintaining proficiency on regulatory requirements and developing and maintaining rapport with FDA reviewers, project team members • Providing continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups. Requirements: • A minimum of a Bachelor's degree in Engineering, Physical or Biological science is required. • MS/Advanced degree is preferred. • Minimum of 8+ years experience in the medical industry is required. • Minimum of 8+ years experience in Regulatory Affairs of Medical Devices is required. • Previous experience with global regulations and regulating agencies is required. • Experience developing PMA submissions for class III medical devices is required. • Prior experience developing IDE submissions is required. • Experience conducting submission negotiations with the FDA, including pre-submission identification of requirements and strategy and post submission negotiations is required. • Previous experience in labeling and promotional material review is a plus. |