Mohan Vijayakumar
Regulatory & Quality Affairs Professional | 5+ Years in Active & Non-Active Implantable Medical Devices | Specializing in Ophthalmic & Neuromodulation Technologies
- Role
- Regulatory Affairs Specialist Ii at 美敦力
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Mohan Vijayakumar
Dynamic and detail-oriented Senior Engineer with 5 years of robust experience in the medical devicequality and regulatory affairs, specializing in both active and non-active implantable devices. Passionate about driving continuous improvement and ensuring the highest standards of safety and efficacy.
Experience
Regulatory Affairs Specialist Ii
Aug 2025 — Present · Hyderabad, IN
Regulatory Affairs Specialist II | Medtronic – Neuromodulation & Pelvic HealthDrive global regulatory strategy and submissions for new and modified medical devices within the Neuromodulation and Pelvic Health portfolio. Partner cross-functionally with R&D, clinical, and international RA teams to secure and maintain global market authorizations.Key responsibilities include developing regulatory strategies, preparing and reviewing premarket submissions, assessing design and labeling changes, and supporting audits and inspections. Experienced in interpreting evolving global regulations and ensuring compliance across the product lifecycle.Currently leading regulatory efforts for GSSD/Hybrid file preparation, streamlining documentation and submission readiness for global product registrations.
Education
Anna University Chennai
Master of Business Administration - MBA, Operations
Vel Tech Multi Tech Dr. Rangarajan Dr. Sakunthala Engineering College
Bachelor of Engineering, Biomedical/Medical Engineering
2016 — 2020
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