Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.

Responsibilities

-Lead and manage regulatory submissions, including preparation, review, and submission of dossiers for

510(k), CE Marking, CDSCO, and other global regulatory approvals.

-Ensure accuracy, completeness, and compliance of all regulatory files and technical documentation.

-Drive end-to-end product regulatory compliance across the product lifecycle, ensuring alignment with applicable global regulations and standards.

-Collaborate with cross-functional teams (R&D;, Quality, and Manufacturing) to gather required documentation and ensure regulatory requirements are integrated into product development.

-Monitor and control the implementation of regulatory requirements within the organization and across projects.

-Stay current with evolving global regulatory requirements, standards, and guidelines applicable to medical devices.

-Interpret regulatory requirements and communicate transparent guidance to internal stakeholders to ensure compliance.

-Conduct regulatory impact assessments and define appropriate regulatory strategies for product approvals and lifecycle changes.

-Support the maintenance and continuous improvement of the Quality Management System (QMS) in line with regulatory requirements.

-Participate in and support internal and external audits related to regulatory compliance.

-Act as PRRC (Person Responsible for Regulatory Compliance), ensuring compliance with applicable regulations (e.g., EU MDR, FDA, CDSCO), including review relevant records and documentation.

-Vigilance reporting to the based on EU and US requirements

-Contribute to the development, review,



and maintenance of risk management documentation in accordance with ISO 14971.

-Post Market surveillance, PSUR, Clinical evaluation report updating in co-ordination with CFTs.

-Review and approve product labeling to ensure regulatory compliance across applicable markets.

-Oversee the creation, review, and maintenance of technical documentation, including regulatory files and

Design History Files (DHF).

-Serve as the primary point of contact with regulatory authorities; manage communications, submissions,

and responses to queries.

-Establish and maintain effective working relationships with regulatory agencies and notified bodies.

-Provide regulatory guidance on product changes, updates, and lifecycle management activities.

-Support departmental objectives and ensure timely execution of regulatory deliverables.

-Propose improvements to QMS structure, processes, or resource allocation to strengthen regulatory compliance.

-Review and approve regulatory procedures, SOPs, and updates to harmonized standards within the QMS.

-Recommend regulatory strategies in response to changes in legislation, guidance, or notified body expectations.

-Ensure escalation and reporting of regulatory events such as vigilance cases and Field Safety Corrective

Actions (FSCA), in compliance with applicable requirements.

Qualifications

Experience Required: 6+ years of Regulatory Affairs job roles

Knowledge Required: Medical Device Regulatory Requirements for India & other countries

Educational Qualification Required : B.E. or higher from appropriate branch (Bio-Medical Engineering preferable)

Technical Skills Required: EU MDD, EU MDR, MDR-2017, US FDA, 510(k), ISO 13485, MS Office

📌 Assistant Manager - Regulatory Affairs (Bengaluru)
🏢 Prognosys Medical Systems
📍 Bengaluru