Regulatory Affairs Associate

Job Description

Role & responsibilities 1. Product Registration & Certification - Support in preparing the documentation as applicable for the product registration and the certifications and submitting in a timely manner. - Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame. 2. Regulatory Audits -Internal and External Audit - Provide assistance in Internal & External audits. - Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner - Assist with follow-up audits, as required. - Follow-ups for the closure against identified NCs during audits. 3. QMS-Maintenance - Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applicable regulatory requirements of - Identify the related and required documents in line with processes ensuring quality standards. - On-time release, distribution & obsolete documents as per the company procedure. - Maintain the QMS documentation, records and file maintenance. - Coordination with other departments for maintaining the documents. - Timely preparation and submission of MIS report on a daily/weekly/monthly basis. Preferred candidate profile Looking for Regulatory affairs professional Experience into Regulations and maintaining the documentation as per the ISO13485, USFDA, MDSAP and other regulations. Overall documentation and guidance to the departments to maintain regulatory compliance.