Rahul Bade
Global Submission | Medical Devices | Health and Life science | ex-TATA ELXSI
- Role
- Senior Regulatory Affairs Specialist at 美敦力
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Rahul Bade
Result-oriented Senior Regulatory Affairs Specialist with extensive experience in the…
Experience
Senior Regulatory Affairs Specialist
Aug 2025 — Present · Hyderabad, IN
Develop and implement regulatory strategies for global markets (FDA, EU MDR, etc.).Prepare and manage regulatory submissions and approvals (e.g, 510(k), CE marking).Ensure product compliance throughout the lifecycle, including labeling and advertising.Monitor regulatory changes and maintain documentation per QMS (e.g, ISO 13485).Support audits, inspections, and post-market activities (e.g, vigilance, reporting).Collaborate cross-functionally with R&D, Quality, Clinical, and Marketing teams.Mentor junior staff and provide regulatory guidance across projects.
Education
Loni Highschool Loni
Ssc
2001 — 2006
Dr. Babasaheb Ambedkar Marathwada University (BAMU), Aurangabad
Bachelor's degree
2008 — 2012
Kalikadevi jr.College
HSC
2006 — 2008
Skills
- Mfg Audit
- Quality Assurance
- Fmea
- Root Cause Analysis
- Management
- Ppap
- Six Sigma
- Spc
- 5s
- 6w2h
- Manufacturing
- Engineering
- Iso 9001
- Geometric Dimensioning
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