Regulatory Affairs Specialist
3 weeks ago
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.
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Regulatory Affairs Specialist
3 weeks ago
Surat, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist
3 weeks ago
Surat, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist
3 weeks ago
Surat, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist
3 days ago
Surat, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist
4 days ago
surat district, India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
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Regulatory Specialist and Senior Specialist
3 days ago
Surat, India Concept Medical Full timeConcept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Manager
2 weeks ago
Surat, India Seven Consultancy Full timeJOB DETAILS Studying scientific and legal documentsGathering, evaluating, organising, managing and collating information in a variety of formats Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) Maintaining familiarity with company product ranges Planning, undertaking and overseeing product trials and...
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Regulatory Affairs Manager
3 days ago
Surat, India Seven Consultancy Full timeJOB DETAILS Studying scientific and legal documentsGathering, evaluating, organising, managing and collating information in a variety of formats Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) Maintaining familiarity with company product ranges Planning, undertaking and overseeing product trials and...
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Regulatory Affairs Executive
1 week ago
Surat, Gujarat, India Trident Lifeline Full time ₹ 5,00,000 - ₹ 15,00,000 per yearONLY EXPERIENCE CANDIDATE CAN APPLYJob description: -We are looking for a Regulatory Affairs Executive with strong knowledge of pharmaceutical products. The candidatemust have experience in domestic regulatory compliance (FSSAI/CDSCO) and export documentation, specifically forLATAM & ROW. Responsibilities include dossier preparation, label review, and...
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Regulatory Affairs Executive
2 weeks ago
Surat, Gujarat, India SALVAVIDAS PHARMACEUTICAL Full time**Qualifications**: Any Graduate of B.Pharm / M.Pharm / MBA (pharmaceuticals/IB) / M.sc / Any Relevant Degree in Pharmaceuticals. **Roles & Responsibility**: - To ensure that a company's products comply with the regulations of the regions where they want to distribute them - To develop explanations for new product licenses and license renewals to strict...
