Must have: FDA Combination Product experience specifically 505(b)(2). Your responsibilities will include the following: • Preparing FDA filings for combination drug/medical device expertise, for combination products.• Supporting & guiding engineering, management, and R&D teams with regulatory strategy with compliance• Providing critical guidance in regulations regarding labeling of drug/device/combination product activities. Visa sponsorship is not available for this position. Responsibilities: Ensure proper implementation of Regulatory Requirements within electronic quality management system. Serve as subject matter expert for regulatory compliance requirements. Keep the c
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