Regulatory Affairs Executive

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.