Website:
topiamedtech.com
Job details:
Job Summary
We are seeking a motivated and detail-oriented QARA Executive with strong hands-on experience in Active Medical Devices and regulatory compliance requirements for India, Europe, and the United States. The candidate should possess practical knowledge of CDSCO regulations, EU MDR requirements, and US FDA 510(k) submissions along with exposure to Quality Management Systems as per ISO 13485.
The role involves preparation and maintenance of regulatory documentation, support for product registrations, implementation of QMS activities, coordination with cross-functional teams, and ensuring compliance throughout the product lifecycle.
Key Responsibilities
· Prepare, review, and maintain regulatory documentation for medical devices.
· Support submissions and approvals under:
o Indian CDSCO Medical Device Rules (MDR) 2017
o EU MDR 2017/745
o US FDA 510(k)
· Prepare and Maintain
o IFU and Labels
o Technical Documentation
o Risk Management Files
· Track changes in global medical device regulations and standards.
· Prepare and update SOPs, formats, records, and quality documents.
· Participate in
o Internal audits
o CAPA activities
o Change control
o Non-conformance management
o Supplier quality activities
· Support design verification and validation activities.
Required Qualification
· Bachelor’s degree in Biomedical Engineering, Electronics Engineering
· Minimum 2 years of experience in QARA for medical devices
· Strong understanding of Active Medical Devices and associated regulations.
· Good documentation, communication, and analytical skills.
Preferred Skills
· Experience with ECG devices, wearable devices, SaMD, or AI-based medical devices preferred.
· Exposure to IEC 60601 testing and compliance.
· Familiarity with clinical evaluation and usability engineering documentation.
· Ability to work independently and manage multiple projects
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