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 recent 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.

📌 Assistant Manager - Regulatory Affairs (Faridabad)
🏢 Polymed
📍 Faridabad