Sudhakar Saxena

Seasoned regulatory, clinical, and quality compliance professional with over 19 years of experience in the medical device industry, seeking the position of Vice President – Regulatory & Compliance. Committed to driving global regulatory strategy, ensuring world-class compliance, and fostering a culture of quality and innovation in product development and commercialization.

• Medical Devices: Orthopedic Implants, Cardiac Devices, Dental Products
• Others: Ocular Devices, Electro-mechanical Devices

• Date of Birth: 05/11/78
• Nationality: Indian
• Marital Status: Married

510(k) Clearance for Total Knee Replacement, MDSAP Certification, MDR Certification for Class IIa & IIb Devices, MDR Certification (Class III – Hip/Knee Replacement, Cardiac Balloon Catheters), 510(k) Submission for Total Hip Replacement

• Lead Auditor – ISO 9001:2015, ISO 13485:2016 & Product Certification
• FDA Uttarakhand Approved: Microbiological testing (Forms 25 & 28), Chemical testing (Form 28)
• 2+ years auditing experience across regulatory bodies and private institutions
• B.Sc. and MBA (Marketing)

• General Manager – Regulatory & Compliance, Biorad Medisys Pvt Ltd, Pune, 06/01/18, Present, Leading all regulatory and compliance initiatives for USFDA submissions and CE certifications for Class III devices., Strategizing regulatory roadmaps aligned with corporate objectives, ensuring successful approvals across global markets., Mentoring cross-functional teams (Regulatory, Clinical, QA) for performance-driven outcomes.
• DGM – Regulatory Affairs & Quality Assurance, Sutures India Pvt Ltd, Bangalore, 11/01/17, 06/01/18, Led regulatory initiatives for surgical and implantable devices across international markets., Strengthened quality systems and audit readiness for global certifications.
• Sr. Manager – Regulatory & Compliance, Biorad Medisys Pvt Ltd, Pune, 07/01/15, 10/01/17, Spearheaded 510(k) submissions and technical documentation for orthopedic implants., Instrumental in aligning internal processes with ISO and MDR requirements.
• Manager – Operations, Zenith Quality Assessors Pvt Ltd, Pune, 04/01/14, 07/01/15, Reviewed technical files for CE marking in accordance with European directives., Conducted audits for ISO 9001, ISO 13485, and CE marking certification., Approved and managed audit schedules including surveillance and recertification.
• Deputy Manager – Quality Assurance, Polybond India Pvt Ltd, Pune, 06/01/11, 04/01/14, Oversaw regulatory submissions and QMS implementation for medical division., Enhanced internal audit and documentation compliance processes.
• Asst. Manager – Quality Assurance, Biomed Healthcare Products Pvt Ltd, Haridwar, 09/01/06, 05/01/11
• Shift In-charge – Quality Control, Wellmed International Pvt Ltd, Noida, 10/01/05, 09/01/06
• Quality Control Supervisor, Polymedicure Ltd, Faridabad, 11/01/01, 10/01/05