Aurolab
Website:
aurolab.com
Job details:
Key Responsibilities:
- Understand and implement the ISO 13485, 21 CFR 820 and EU MDR regulations
requirements with respect to devices.
- Executive to maintain the documents and records are in compliance with USFDA regulations, ISO 13485 and EU MDR requirements.
- Prepare and update the documentation for ISO 13485, EU MDR and 510(k) submission.
- Addressing notified bodies queries and USFDA queries.
- Provide support for regulatory inspections and audits related to USFDA, ISO 13485 and EU MDR.
- Maintain audit reports and documentation of USFDA Audit, ISO 13485 and EU MDR audit performed.
- Collaborate with respective Division’s QA Manager / QA Engineer / Division’s RA/Clinical team and other stakeholders.
- Assist with RA Manager.
- Ensure CAPA (Corrective and Preventive Actions) are implemented and maintained in response to audit findings.
Qualification: Bachelor’s degree in pharmacy (B. Pharm)
Experience: 1 – 5 years of professional experience in Regulatory Affairs within the medical
device or healthcare industry.
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