Regulatory Specialist and Senior Specialist
3 days ago
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 Netherlands to further our mission of saving lives and improving patient care. We are seeking a dedicated and knowledgeable Regulatory Specialist to ensure our medical devices meet local and international regulatory standards. The ideal candidate will have extensive knowledge of CDSCO, ISO, FDA, and other regulatory requirements, ensuring the highest standards of safety and efficacy for our products. Develop regulatory strategies for new/existing products. - Ensure compliance with local/international regulations (CDSCO, ISO, FDA). - Prepare and submit regulatory submissions. - Monitor regulatory developments and adjust strategies. - Liaise with regulatory bodies and internal teams for compliance. - Conduct audits and maintain up-to-date knowledge of regulatory requirements. Bachelor’s degree in a scientific discipline. - 5 to 7 years’ experience in regulatory affairs within the medical device industry. - Experience with regulatory submissions and medical device development. - Excellent communication, organizational, and project management skills. Professional certification in regulatory affairs (RAC).
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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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Surat, Gujarat, India Hirvexa Tech Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 12,00,000 per year𝐖𝐞'𝐫𝐞 𝐇𝐢𝐫𝐢𝐧𝐠 𝐚𝐭 𝐒𝐦𝐚𝐫𝐭𝐁𝐢𝐳 𝐛𝐲 𝐀𝐦𝐚𝐳𝐨𝐧 | MD IMPEX 𝐏𝐨𝐬𝐢𝐭𝐢𝐨𝐧𝐬 𝐎𝐩𝐞𝐧: Junior & Senior Meta (Facebook & Instagram) Ads Specialist. 𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧: Surat, Gujarat.Are you someone who lives and breathes digital marketing?Join our...
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Regulatory Affairs Specialist
3 weeks ago
Surat, India Zydus MedTech Full timeJob 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...
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Regulatory Affairs Specialist
3 weeks ago
Surat, India Zydus MedTech Full timeJob 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...
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Regulatory Affairs Specialist
3 weeks ago
Surat, India Zydus MedTech Full timeJob 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...
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Regulatory Affairs Specialist
3 weeks ago
Surat, India Zydus MedTech Full timeJob 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...
