Website AgNovos Healthcare
AgNovos Healthcare
Company : AgNovos Healthcare
Job Description
You will primarily assist in the preparation of regulatory submissions for AgNovos’ lead product to ensure compliance with regulatory requirements in the EU, US FDA, and regulatory bodies in other countries. Working with both internal teams and external consultants, you will provide overall regulatory support, including but not limited to FDA meeting preparations, archiving documentation, making entries into and maintaining the regulatory database and file storage system.
Additional responsibilities may include regulatory support for Manufacturing/Operations and Quality Assurance primarily in the area of regulatory compliance, document and records management. A successful individual in this role will need to be highly organized with attention to details.
Essential Duties and Responsibilities:
Coordinate and provide regulatory support for international regulatory submissions and FDA submissions (e.g., IDE and PMA). Responsibilities including but not limited to proofread and format documentation, follow up closely on internal review process and compile updated document based on feedback, ensure accuracy and consistency of documents intended for submissions, etc.
Maintain and update Technical Files and Design Dossiers upon request to ensure compliance with current regulatory and company standards
Coordinate and prepare materials and presentations for internal meetings and FDA meetings, utilizing Microsoft Office Suite tools
Maintain tracking tools for all regulatory submissions, communications and documentation
Maintain and update the regulatory synopses for all regions
Provide support to the Quality Assurance department for document control, audits, complaint handling, and CAPAs
Track reporting requirements and filing deadlines and keep the team informed
Coordinate with Manufacturing/Operations and complete regulatory requirements for Import/Export/Customs
Review regulations and guidance to keep apprised of regulatory changes and new regulatory developments
Demonstrate ability in the application of requisite skills and applies additional skills and knowledge acquired through experience to perform the more complex tasks of the position
Additional projects as assigned