Details: The primary purpose of this job is to develop strategies for worldwide governmental approval to introduce new products to market, provides advice on regulatory requirements, prepares global submissions and negotiates their approval. The incumbent also assists with the training of less senior regulatory affairs personnel and provides work direction on projects of large scale. This position will also include the role of legal representative for Greatbatch, they will be the interface with EU regulatory bodies. Key Accountabilities and Responsibilities 1. Adheres to GB Core Beliefs and all safety and quality requirements. 2. Clinical affairs support for regulatory submissions including clinical evidence reports, Report of Priors, initial clinical plan for new programs 3. Maintain Regulatory Affairs product files to support compliance with regulatory requirements. 4. Prepare submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. 5. Prepare regulatory strategies/plans and worldwide requirements lists. Negotiate submission issues with agency personnel. 6. Provide on-going support to product development teams for regulatory issues and questions. 7. Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. 8. Performs other functions as required.
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