Regulatory Affairs Senior Consultant - QARA

Job Description

Job Title: Regulatory Affairs Senior Consultant - QARA

Location: Bangalore

Experience: 812 Years

Type: Full-Time

Job Summary:

We are seeking an experienced Senior QARA Consultant with strong expertise in Regulatory Affairs for Medical Devices, IVD, and SaMD products . The ideal candidate will lead regulatory submissions, product registrations, and compliance activities while working closely with cross-functional teams to ensure adherence to global regulatory standards. This role requires deep domain knowledge, strong documentation skills, and the ability to operate independently in a consulting capacity.

Key Responsibilities:

• Lead and manage Regulatory Affairs activities for Medical Devices, IVD, and SaMD products
• Prepare, review, and submit regulatory dossiers including 510(k), PMA, CE Marking, EU MDR/IVDR, and CDSCO submissions
• Handle product registrations and regulatory submissions across global markets
• Ensure compliance with US FDA, EU MDR/IVDR, EMA , and other applicable regulations
• Support quality management system (QMS) activities aligned with ISO 13485 and ISO 14971
• Coordinate and support internal and external audits , regulatory inspections, and authority queries
• Collaborate with R&D, QA, clinical, and business teams to ensure regulatory readiness
• Participate in governance meetings, provide regulatory guidance, and support decision-making
• Maintain regulatory documentation, technical files, and compliance records

Required Skills & Experience:

• 812 years of experience in Quality Assurance & Regulatory Affairs (QARA)
• Strong experience in Regulatory Affairs for Medical Devices / IVD / SaMD
• Proven expertise in product registrations and regulatory submissions
• Hands-on experience with EU MDR, IVDR, US FDA, 510(k), PMA, CE Marking
• Strong knowledge of ISO 13485, ISO 14971 , and QMS processes
• Experience working with cross-functional and global teams
• Excellent communication, documentation, and stakeholder management skills

Good to Have:

• Exposure to CSV / CSA, GxP , and SDLC/Agile environments
• Experience with regulatory tools such as Microfocus ALM, Jira , or similar
• Prior experience in consulting or regulated enterprise environments