Iulia Constantin Email and Phone Number

- Study scientific and legal documents- Maintain familiarity with company product ranges- Keep up to date with changes in regulatory legislation and guidelines- Liaise and negotiate with regulatory authorities - Provide advice about regulations to manufacturers - Write comprehensible, user-friendly, clear product information leaflets and labels- Ensure that quality standards are met and submissions meet strict deadlines- Prepare necessary documentation for products dossiers- Prepare additional information or responses as requested by regulatory agencies- Compile and maintain regulatory documentation databases- Escort inspectors from authorities during inspections and provide post-inspection follow-up information as requested- Review product promotional, marketing material and external communications for compliance with applicable regulations and policies- Recommend changes to company procedures in response to changes in regulations or standards- Responsible for the vigilance of existing medical devices in the company portfolio and maintain the relationship with the National Medicines Agency and Medical Devices