Hays | Regulatory Affairs Officer | new delhi
5 days ago
for
Regulatory Affairs in Medical Device Compliance
Workload:
Approximately
40-50 hours
per year , on-call
Key Requirements :Expertise in Indian Medical Device Regulations : Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for
Class C and D products .Regulatory Experience : Proven experience in obtaining regulatory approvals and maintaining licenses for medical devices, including change reporting and renewals.Scientific Background : Ideally, a background in a scientific discipline
Responsibilities :Regulatory Consulting : Provide expert advice on the implementation of Indian medical device regulations.Support Change Assessments : Assist with the execution of change assessments, query responses, new product registrations, and renewals.Submission Dossiers : Aid in the preparation of submission dossiers in compliance with Indian
regulatory authorities and Indian MDR
(Medical Device Rules).Review and Submission : Review and submit applications (changes, renewals, new product registrations) via the
CDSCO
(Central Drugs Standard Control Organization) portal.Communication with Authorities : Coordinate with local authorities in collaboration with the authorized agent.Vigilance Support : Provide support in handling vigilance cases.License Optimization : Offer advice on optimizing existing licenses, such as cost reduction strategies.Predicate Evaluation : Ideally, support the evaluation of suitable predicates for product registration.
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New Delhi, India Hays Full timeOn-Call Contractor for Regulatory Affairs in Medical Device ComplianceWorkload: Approximately 40-50 hours per year , on-callKey Requirements :Expertise in Indian Medical Device Regulations : Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for Class C and D products .Regulatory Experience : Proven...
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new delhi, India Hays Full timeOn-Call Contractor for Regulatory Affairs in Medical Device ComplianceWorkload: Approximately 40-50 hours per year, on-callKey Requirements:Expertise in Indian Medical Device Regulations: Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for Class C and D products.Regulatory Experience: Proven experience...
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new delhi, India Hays Full timeOn-Call Contractor for Regulatory Affairs in Medical Device Compliance Workload: Approximately 40-50 hours per year , on-call Key Requirements : Expertise in Indian Medical Device Regulations : Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for Class C and D products . Regulatory Experience : Proven...
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New Delhi, India Hays Full timeOn-Call Contractor for Regulatory Affairs in Medical Device ComplianceWorkload: Approximately 40-50 hours per year , on-callKey Requirements :Expertise in Indian Medical Device Regulations : Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for Class C and D products.Regulatory Experience : Proven...
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Regulatory Affairs Officer
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New Delhi, India Hays Full timeOn-Call Contractor for Regulatory Affairs in Medical Device Compliance Workload: Approximately 40-50 hours per year , on-call Key Requirements : Expertise in Indian Medical Device Regulations : Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for Class C and D products . Regulatory Experience : Proven...
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New Delhi, India Hays Full timeOn-Call Contractor for Regulatory Affairs in Medical Device ComplianceWorkload: Approximately 40-50 hours per year, on-callKey Requirements:Expertise in Indian Medical Device Regulations: Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for Class C and D products.Regulatory Experience: Proven experience...
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New Delhi, India Hays Full timeOn-Call Contractor for Regulatory Affairs in Medical Device ComplianceWorkload: Approximately 40-50 hours per year, on-callKey Requirements:Expertise in Indian Medical Device Regulations: Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for Class C and D products.Regulatory Experience: Proven experience...
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