Job discription Manager-Medical Device We are looking for a young agile professional for the position of Manager-Medical Devices the position will be responsible for Managing regulatory submissions to ensure timely filing as per the requirement of national and international regulatory including FDA 510 k CDSCO CE Marking and others Performing Gap assessment Responding to regulatory queries Conducting internal quality audits as per ISO standards Providing support for ISO Certification including ISO 13485 ISO11135 ISO 11137 ISO 11737 ISO 14971 and other relevant standards Verification of design and development documentation and validation Collaborate with quality team to ensure effective implementation of quality management systems You should have Strong knowledge of global medical device regulations and standards Experience with preparation regulatory submissions and certification management including FDA 510 k CDSCO Medical Device Registration Import and Manufacturing Licenses in India CE Marking under the EU Medical Device Regulation MDR Saudi Food and Drug Authority SFDA requirements for Saudi Arabia UK CA Marking for the United Kingdom Knowledge of 21 CFR 820 is desirable Excellent project management and organizational skills Ability to collaborate with cross-functional teams Strong analytical and problem-solving skills Able to articulate thoughts clearly concisely and professionally in English Well versed in Microsoft Word Excel PowerPoint Knowledge of 21 CFR Part 11 is an added advantage Qualification Bachelor s or Master s degree in pharmacy Engineering Regulatory Affairs Life Sciences or a related field Experience 2 - 8 years Location Pimpri Chinchwad Pune contact us 91121 18881 Job Type Full-time Pay 480 000 00 - 720 000 00 per year Work Location In person

📌 Manager-medical Device (Maharashtra)
🏢 Micron Air Filters and Equipment Private
📍 Maharashtra