Regulatory Affairs Manager

2 weeks ago

Surat, India Zydus MedTech Full time

Job Purpose:To lead regulatory submissions and compliance activities for cardiovascular medical devices, specifically drug‑eluting stents, balloon catheters, and related vascular devices. Ensure adherence to Indian Medical Device Rules (MDR 2017), ISO 13485, and EU MDR.Key Responsibilities: - Prepare and submit regulatory applications for stents and catheter systems (CDSCO Forms MD‑5/6/7/8/14/15/16) - Compile and manage technical documentation, DMF, STED (Summary Technical Documentation), CER (Clinical Evaluation Report), RMR (Risk Management Report), Biocompatibility records, Animal Study Reports. - Ensure compliance with MDR‑2017, EU MDR 2017/745 and applicable ISO standards (ISO 25539, ISO 10993, etc.) - Maintain CDSCO manufacturing/import licenses, QMS certificates, Notified Body certifications - Review IFU, labelling, packaging artwork claims - Handle regulatory change control for product and process modifications - Liaise with CDSCO, notified bodies, regulatory consultants, test labs (chemical, mechanical, biocompatibility, stability) - Assist in vigilance reporting, and field corrective action - Maintain UDI compliance & track PMS reports and risk management documentation (ISO 14971) - Support internal, customer, and notified body audits.

  • Regulatory Affairs Lead

    2 weeks ago

    surat, India beBeeRegulatory Full time

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    surat, India beBeeRegulatory Full time

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    1 week ago

    Sachin, Surat, Gujarat, India Globela Pharma Pvt. Ltd. Full time

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    4 days ago

    Surat, Gujarat, India Trident Lifeline Full time

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    6 days ago

    Surat, Gujarat, India Discrete Circuits Pvt. Ltd Full time

    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...

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    1 week ago

    Surat, India Elevate Life Science Full time

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    3 days ago

    surat, India beBeeRegulatory Full time

    Job OverviewWe are seeking a seasoned professional to fill the role of Senior Regulatory Affairs Associate.The successful candidate will possess in-depth knowledge of regulatory frameworks and procedures, enabling them to effectively manage submissions and applications across various regions.ResponsibilitiesRegulatory Submission Management: Collaborate with...

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    2 weeks ago

    Surat, Gujarat, India Trident Lifeline Pvt. Ltd. Full time

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    3 weeks ago

    Surat, India Seven Consultancy Full time

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    2 days ago

    Surat, India Seven Consultancy Full time

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