Regulatory Affairs Specialist
3 weeks ago
About 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 Netherlands to further our mission of saving lives and improving patient care. Job Summary: 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. Key Responsibilities: - 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. Required Qualifications: - Bachelor's degree in a scientific discipline. - 5 to 7 years' experience in regulatory affairs within the medical device industry. - In-depth knowledge of CDSCO, ISO, FDA standards. - Experience with regulatory submissions and medical device development. - Excellent communication, organizational, and project management skills. Preferred Qualifications: - Advanced degree (Master's/Ph.D.). - Professional certification in regulatory affairs (RAC).
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Regulatory Affairs Specialist
1 week ago
Noida, India Gentell Full timeJob Description Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life. Our success is a...
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▷ [Urgent] Regulatory Affairs Specialist
3 weeks ago
Gurugram, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added...
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Regulatory Affairs Operations Specialist
4 weeks ago
Pune, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: - International Registrations - Upload, Verify, and Validate the data with new Regulatory Information to the RIM database - Maintain Registration &Licensing Information - Create Submission Packages for International Registrations - Initiate Renewals with...
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India G&L Scientific Full timeWe are seeking three Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle management activities. This opportunity can be...
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Regulatory Affairs Associate
2 weeks ago
India Cisbio Full time**Responsibilities**: Location India - Remote, IN Job ID JR-031455 PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Specialist will support our Diagnostics Business that focuses on products targeted to improve human health. He/she will support regulatory submissions...
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Senior Compliance
2 weeks ago
India Hemant Surgical Industries Limited Full timeJob Title: Senior Compliance & Regulatory Affairs Specialist (Medical Devices) Location: Mumbai Department: Regulatory Affairs / Quality Assurance Experience Required: 7–12+ years Industry: Medical Devices / Healthcare / Pharma ______________ Job Summary: The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities related to...
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Regulatory Specialist and Senior Specialist
2 weeks ago
India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life. Our success is a result of the...
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Senior Compliance
1 week ago
Mumbai, India Hemant Surgical Industries Limited Full timeJob Description Job Title: Senior Compliance & Regulatory Affairs Specialist (Medical Devices) Location: Mumbai Department: Regulatory Affairs / Quality Assurance Experience Required: 712+ years Industry: Medical Devices / Healthcare / Pharma ______________ Job Summary: The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities...
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[3 Days Left] Regulatory Affairs Specialist
3 weeks ago
India Dr. Reddy's Laboratories Full timeJob Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Specialist
17 hours ago
Pune, India Atlas Copco Full timeJob Description Our solutions are a key part of most industries - electronics, medical research, renewable energy, food production, infrastructure and many more. Working with us means working with the latest technologies and groundbreaking, sustainable innovations. Join us on our journey for a better tomorrow. Your Role- Purpose - Gecia is supporting Atlas...
