Bablu Pashwan — Operations Associate

I am a dedicated and detail-oriented Deputy Manager – Quality & Regulatory Affairs with over 10 years of experience in the medical device industry, specializing in Class B medical devices such as clear dental aligners. I combine strong technical expertise with global regulatory strategy to ensure every product meets international quality, safety, and compliance expectations. As a Certified ISO 13485:2016 Lead Auditor (CQI | IRCA, TÜV SÜD), I bring a high level of audit rigour and QMS leadership, enabling organizations to maintain audit-ready systems, reduce compliance risks, and achieve seamless regulatory approvals across global markets. I have hands-on experience with multiple regulatory frameworks, including CDSCO (India), US FDA 510(k), SFDA (Saudi Arabia), EU MDR, IMDR, and APAC markets (Singapore HSA CSDT, Hong Kong, Vietnam)—allowing me to lead end-to-end regulatory submissions and global market entry strategies. 🛠️ Core Expertise Lead Auditor (ISO 19011, ISO 13485) – Internal & external audits with a track record of zero major NCs ISO 13485:2016 QMS implementation, maintenance & certification surveillance Global regulatory compliance: CDSCO, US FDA 510(k), SFDA MDMA, EU MDR, IMDR, APAC (HSA CSDT) CAPA management, NCR handling, root cause analysis & ISO 14971 risk management Regulatory submissions: site transfers, SFDA MDMA, CDSCO MD-5/MD-42, FDA Establishment Registration & Device Listing QMS documentation: document control, design transfer, process validation, vendor qualification GMP, HACCP, Lean Six Sigma, and process optimization for cost-effective compliance 📜 Certifications & Credentials ISO 13485:2016 Lead Auditor (CQI | IRCA, TÜV SÜD) Internal Auditor – ISO 13485:2016 MD-QMS Certified in Biocompatibility, GMP, HACCP, and ISO 14971 Risk Management ISO 9001 – QMS Fundamentals Lean Six Sigma – Yellow & Green Belt Advanced training in RCA, Statistics, Business Process Mapping & Operational Excellence ⚙️ Passion & Vision I am passionate about driving regulatory excellence, building sustainable QMS frameworks, and enabling organizations to achieve global medical device compliance while improving operational efficiency. I strongly believe in mentoring teams, promoting continuous improvement, and ensuring patients receive safe, reliable, and high-quality products. 📬 Open To Knowledge-sharing, collaborations, and leadership opportunities in Quality Assurance, Regulatory Affairs, Medical Device Compliance, and QMS Management.

Stackforce AI infers this person is a Quality and Regulatory Affairs expert in the Healthcare industry.

Location: Mumbai, Maharashtra, India

Experience: 10 yrs 7 mos