Medical Device Regulatory Lead
3 weeks ago
About the Role We are looking for a Medical Device Regulatory Leadwith4–6 years of proven hands-on experiencein medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities includingUS FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other global regulatory agencies. This role requires leadership, ownership, and the ability to guide cross-functional teams through complex regulatory pathways.Key Responsibilities Lead the preparation, submission, and management of medical device applications (US FDA 510k, CE Marking, MDSAP, CDSCO, and other markets). Ensure compliance with regulatory standards includingISO 13485, 21 CFR 820 , and other applicable regulations. Act as the primary contact for Health Authorities, managing queries and responses effectively. Oversee regulatory strategy, project planning, and execution for medical device submissions. Provide guidance onQuality Management Systems (QMS)and support audits/inspections. Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Clinical, Commercial) to align regulatory requirements with business objectives. Take ownership of projects, demonstrating leadership and accountability in delivery.Qualifications 4–6 years of experience inmedical device regulatory affairs . Proven track record with submissions toFDA (510k), CE Marking, CDSCO, and other agencies . Strong knowledge ofISO 13485, 21 CFR 820, QMS practices, and international medical device regulations . Experience in responding to Health Authority queries and managing regulatory communications. Excellent project management, organizational, and leadership skills. Ability to work independently, take ownership, and drive results.Why Join Us Opportunity to lead regulatory projects across global markets. Work in a dynamic, entrepreneurial, and collaborative environment. Be at the forefront of advancing compliance and patient safety in medical devices. Apply now via LinkedIn or connect with us to explore this opportunity
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3 Days Left: Area Sales Manager
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Delhi, India Fanem medical device Full timeJob description - Position Title Area Sales Manager -Delhi- Department Sales Marketing- Location Should be based in Delhi need to handle North Region- Reporting To National Sales Head Key Responsibilities - Drive sales of medical devices within the assigned territory to meet or exceed targets- Build and maintain strong relationships with hospitals clinics...
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System engineer
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Delhi, 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 Affairs Specialist
3 days ago
Delhi, 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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New Delhi, India Cipla Full timeJDRole is to take the lead and conduct device development for Meter Dose Inhaler dosage form. Primary role is to co-ordinate with device manufacturers for selecting the right device and responsible for conduiting design verification to comply the defined user requirements. The candidate will be responsible for test method /fixtures development, relevant...
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System Integrator – Medical Devices
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Senior Microbiology Trainer – Medical Devices
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Delhi, India ELT Corporate Private Limited Full timeJob Description Experience: 1-2 years Location: Rohini Sector-3, New Delhi Company: ELT Corporate Private Limted About us: We are a leading consultancy providing comprehensive regulatory affairs and compliance services for medical devices across India and international markets including UAE, USA (USFDA), and Europe (CE / EU MDR). Our mission is to help...
