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Job Description
- Provide responses to Regulatory Agencies regarding product information or issues
- Align Regulatory Affairs planning with business strategy and commercial objectives to ensure full synchronization and harmony
- Coordinate QPPV related tasks and responsibilities
- Develop and maintain standard operating procedures or local working practices
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Manage activities such as audits, regulatory agency inspections, or product recalls
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
Job Requirements
- More than 5 years
- Bachelor's Degree at least
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