Assistant Manager - Regulatory Affairs

Key Responsibilities :

• Ensure that all products comply with global, regional, and national regulatory requirements (e.g., FDA 21cfr part 820, EU MDR 2017/745, ISO 13485, MDSAP).
• Preparation and maintenance of Technical Documentation (Technical Files and Design Dossiers) in accordance with Annexes II and III of the EU MDR.
• Monitor changes in regulations, standards, and guidelines relevant to the companys product portfolio, ensuring timely implementation of necessary updates.
• Coordinate with internal teams (e.g., R&D, Quality, and Manufacturing) to ensure products are developed, manufactured, and distributed in compliance with applicable regulations.
• Oversee and manage the submission and maintenance of regulatory dossiers for product registrations, renewals, and variations (e.g., FDA 510(k), EU Technical Files, CE marking, Health Canada licenses etc).
• Develop and manage the Post-Market Surveillance (PMS) system, including the preparation of Periodic Safety Update Reports (PSURs) for Class IIa, IIb, and III devices and Post-Market Clinical Follow-up (PMCF) plans and reports.
• Develop and implement regulatory strategies for new product development, ensuring that regulatory requirements are integrated into product design and development processes.
• Provide regulatory guidance during product lifecycle management, including design changes, manufacturing changes, and labelling updates.
• Address and close any non-conformities raised during any inspections or regulatory audits, ensuring corrective and preventive actions (CAPA) are implemented effectively and efficiently.
• Review and approve product labelling, advertising, and promotional materials to ensure compliance with regulatory requirements.
• Maintain records of all regulatory submissions, communications with authorities, and approvals for internal audits and compliance purposes.
• Manage the lifecycle of regulatory documentation, ensuring that all documents are accurate and retrievable for audits or inspections.
• Evaluate the impact of regulatory changes on the company's products and operations and communicate necessary actions to senior.
• Ensure that any product changes, process changes, or QMS changes are thoroughly evaluated and submitted to the Notified Body when required, per MDR’s change control requirements.
• Review and approve marketing and promotional materials to ensure alignment with the EU MDR and avoid non-compliant claims.
• Provide regulatory training to internal teams to ensure understanding and compliance with regulatory requirements.
• Stay up to date with global regulatory trends, guidance documents, and best practices, ensuring the company remains proactive in its approach to compliance.