Regulatory Affairs Medical Devices Specialist

We're Hiring! | Regulatory Affairs – Medical Devices Specialist (Experienced) in Ahmedabad
Company:  Elevenclock Healthcare Pvt. Ltd.
Industry:  Medical Devices (Export)

Location:

B-306, 307, 1308, Ganesh Glory 11, Jagatpur Road, Gota, Ahmedabad – 382481

Employment Type:

Full-time
Experience Level:  Experienced Professionals
About the Role  Elevenclock Healthcare Pvt. Ltd. is seeking an  experienced Regulatory Affairs Executive – Medical Devices  to manage  medical device registrations and regulatory compliance  for domestic and international markets. This position is strictly for medical devices and does not involve pharmaceutical regulatory work.

Key Responsibilities   Prepare, review, and submit  medical device regulatory dossiers  in compliance with  CDSCO, MDR 2017, and applicable international regulations
Manage medical device registrations, renewals, variations, and amendments
Coordinate with regulatory authorities for approvals, deficiency responses, and compliance updates
Ensure continuous compliance with national and international medical device regulations
Maintain medical device licenses, technical files, and regulatory documentation
Support regulatory audits, change management, and post-approval activities
Collaborate closely with QA, QC, and Production teams  to ensure regulatory compliance
Qualifications & Experience   Bachelor's degree in  Pharmacy, Biomedical Engineering, Life Sciences , or a related discipline
Hands-on experience in Regulatory Affairs for Medical Devices only
Strong knowledge of Medical Device Rules (MDR 2017), CDSCO , and device registration processes
Familiarity with  ISO 13485 , technical documentation, and export regulatory requirements preferred
Strong communication, coordination, and documentation skills
Ability to manage  multiple medical device submissions and timelines  effectively

How to Apply

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#We Are Hiring  #Medical Devices #Regulatory Affairs #Medical Device Registration  #CDSCO #MDR
2017 #Medical Device Export  #Ahmedabad Jobs #Elevenclock Healthcare