Medical Device Regulatory Lead
3 days 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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Medical Device Regulatory Lead
1 week ago
New Delhi, India ArtiXio Full timeAbout the RoleWe are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
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(Apply Now) Medical Device Regulatory Lead
3 weeks ago
Delhi, India ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other...
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Manager - Regulatory Affairs - Medical Devices
2 weeks ago
New Delhi, India WhiteCrow Research Full timeAbout are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our clients in-house our clientOur client...
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System engineer
1 day ago
New Delhi, India Tata Elxsi Full timeTata Elxsi is among the world’s leading providers of design and technology services across industries, including Automotive, Broadcast, Communications, and Healthcare. Tata Elxsi is helping customers reimagine their products and services through design thinking and the application of digital technologies such as IoT (Internet of Things), Cloud, Mobility,...
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Regulatory Affairs Specialist
3 days ago
New Delhi, India Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office , Near Thaltej Crossroads Department:RA Reports To:RA Head and Regulatory Department at HO /Director Employment Type:Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday andSaturday Half Day Preferred Gender: M/F Experience : Minimum 2 yearsJob Summary: We are seeking a proactive...
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Team Member/Manager
3 days ago
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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New Delhi, India Tek Support Full timeJob Title:Senior Microbiology Trainer – Medical Devices Location:Remote Job Type:Part-timeJob Summary: We are seeking an experienced Microbiologist with over 10 years of hands-on expertise in microbiology, sterilization, and quality assurance in the medical devices industry. The ideal candidate will design, develop, and deliver training programs to enhance...
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Program Officer, Medical Devices
2 weeks ago
Delhi, Delhi, India The Bill & Melinda Gates Foundation Full timeThe Foundation We are the largest nonprofit fighting poverty, disease, and inequity around the world. Founded on a simple premise: people everywhere, regardless of identity or circumstances, should have the chance to live healthy, productive lives. We believe our employees should reflect the rich diversity of the global populations we aim to serve. We...
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New Delhi, India Tek Support Full timeJob Title:Senior Electrical Engineering Trainer – Pharma & Medical Devices Location:Remote Job Type:Part-timeJob Summary: We are seeking an experiencedElectrical Engineering Trainerwith over10 years of hands-on experiencein the pharmaceutical and medical devices industries. The trainer will be responsible for designing, developing, and delivering...
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Regulatory Affairs Lead, Project Manager
3 days ago
New Delhi, India ArtiXio Full timeAbout the Role We are looking for a Regulatory Affairs Lead/ Project Managerto join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to...
