Compliance Executive

1 day ago


Amarnath MH IN Alan Electronic Systems Pvt. Ltd. Full time

Role Compliance and Audit Executive Medical Devices Location Ambarnath Band 5B Roles Responsibilities Collaborate with cross-functional teams to ensure compliance with MDR India 2017 EU MDR 2017 745 US FDA 21 CFR Part 820 MDSAP requirements ISO 13485 2016 ISO 9001 2015 and other applicable regulatory requirements as implemented Review update and improve existing SOPs Work Instructions Policies and QMS documentation across departments to maintain regulatory compliance Prepare review and compile Technical Documentation Device Master Files DMF in accordance with applicable regulatory standards Perform and support Risk Management activities as per ISO 14971 including risk analysis evaluation control and reporting Demonstrate sound knowledge of Process Validation Design Controls and Software Verification Validation V V activities Support regulatory compliance related to the import manufacture distribution and sale of medical devices in India Conduct internal audits and provide support during external audits Notified Bodies Regulatory Authorities Customers Handle Post-Market Surveillance PMS activities including complaint handling vigilance reporting and trend analysis Apply Root Cause Analysis RCA techniques and manage Corrective and Preventive Actions CAPA effectively Education and Experience Bachelor s degree in Science or Engineering Biomedical Electronics Mechanical or related disciplines 0-2 years of experience in regulatory compliance quality assurance or the medical device industry ISO 13485 Internal Auditor Lead Auditor certification is an added advantage Exposure or hands-on experience with US FDA regulations and MDSAP audits will be an added advantage Strong analytical skills with the ability to interpret and apply complex regulatory and quality requirements High learning agility with demonstrated aptitude for understanding and implementing regulatory standards Job Type Full-time Pay 20 000 00 - 50 000 00 per month Benefits Food provided Health insurance Provident Fund Work Location In person


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