Aurolab
Website:
aurolab.com
Job details:
Job Summary:
The Regulatory Affairs (RA) Executive is responsible for supporting regulatory compliance
activities for medical devices in accordance with ISO 13485, US FDA (21 CFR Part 820), and
EU MDR requirements. The role involves preparing and maintaining regulatory
documentation, supporting product registrations and submissions, addressing regulatory
queries, coordinating audits and inspections, and collaborating with cross-functional teams to
ensure ongoing compliance. The incumbent will assist in implementing corrective and
preventive actions (CAPA), maintaining regulatory records, and supporting the organization’s
quality and regulatory objectives.
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.
Experience: 1 – 3 years of professional experience in Regulatory Affairs within the medical
device or healthcare industry.
Skills: Problem solving, query addressing, Proficiency in MS Office tools, Ability to
coordinate cross-functional teams, Effective communication skills.
Click on Apply to know more.
