Regulatory Affairs Executive

2 days ago

Surat, Gujarat, India Discrete Circuits Pvt. Ltd Full time ₹ 4,00,000 - ₹ 12,00,000 per year

About the Company Embarking on the frontier of technological progress, Discrete Circuits Pvt. Ltd. takes pride in its commitment to pioneering innovation and delivering state-of-the-art solutions that dynamically cater to our customers' evolving needs. Our journey unfolds through a comprehensive process, beginning with extensive research, leading to meticulous development, followed by rigorous testing, seamless production, and culminating in unwavering commitment to quality control. Join us in shaping the future of electronics, where innovation and customer satisfaction guide our journey.

Position Overview:-

We are seeking a Regulatory Affairs Executive to manage certifications, audits, and regulatory compliance for our medical device division. This role ensures alignment with ISO 13485, CDSCO, CE, EU MDR, and other international standards, while maintaining documentation and certification renewals. The incumbent will serve as the key link between internal teams and external auditors, ensuring audit readiness, compliance, and continuous improvement.

Key Responsibilities


• Manage certifications and renewals for ISO 9001, ISO 13485, CDSCO, CE marking, and EU MDR.


• Prepare and maintain technical documentation, device master files, and QMS records.


• Monitor regulatory updates and implement necessary changes to remain compliant.


• Ensure audit readiness for internal, external, and regulatory audits.


• Coordinate with auditors, certification bodies, and regulatory authorities.


• Maintain audit trackers and ensure timely closure of non-conformities through CAPA.


• Prepare, review, and submit dossiers, SOPs, risk assessments, and regulatory filings.


• Maintain robust documentation systems to support certifications and renewals.


• Support product registrations and compliance activities with CDSCO and international agencies.


• Conduct internal training sessions on regulatory compliance and certification requirements.


• Ensure employees are updated on changes in standards (ISO, MDR, CDSCO).


• Maintain training and compliance records for audit purposes.

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