Associate Manager - Regulatory Affairs& quality

Job Boosts

Role & responsibilities

• Oversee and manage regulatory activities related to healthcare products, ensuring compliance with applicable laws and regulations.
• Lead regulatory submissions, including preparing and reviewing documents for product registrations and approvals.
• Ensure that no new product is placed on FDA's import alert from the legitimate shipments.
• Maintain all document dossier for regulatory submission.
• Serve as the primary point of contact for regulatory agencies, establishing and maintaining positive relationships to facilitate approvals and compliance.
• Lead and provide expert guidance on US detention regulations and ensure the organization's adherence to quality standards.
• Collaborate cross-functionally with internal teams such as R&D, Quality Assurance, and Legal to ensure regulatory requirements are integrated into product development processes.
• Stay abreast of regulatory changes and industry trends, and communicate updates to relevant stakeholders.
• Conduct internal audits to assess and enhance regulatory compliance and quality assurance processes.

Assist in the development and implementation of regulatory strategies to support product launches and lifecycle management