Vaisesika - Senior Consultant - Regulatory Affairs - QARA
3.9
47+ Reviews
Job Title: Regulatory Affairs Senior Consultant - QARA
Location: Bangalore
Experience: 8-12 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
- 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:
- 8-12 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
Didn’t find the job appropriate? Report this Job
