Karthik S.
Regulatory Affairs Specialist
- Role
- Ra Specialist at Philips
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Karthik S.
Well versed with Medical device registration/approval for international regulatory submissions, primarily for the EU, APAC, LATAM, MET and ANZ markets. Plan and track Submission of LCM/NPI products, Managed timelines, and product registration, including product license renewals.Worked within the framework of a team to perform premarket and post-market activities, providing support throughout the total product lifecycle.Developed and implemented a labeling strategy to comply with EU and country-specific regulations.Activities include working with RA Specialists and other cross-functional team associates to develop regulatory plans and deliverables list for product changes.Assisted internal & external Audits for Regulatory.My goal is to pursue a challenging and satisfying career in the medical device sector, which would provide me the chance to accomplish the objectives of the company and apply this experience to my personal and professional development.Insolare Energy Pvt Ltd:Designing of Solar power plant roof top and ground mount (Fixed & Tracker) along with execution and commissioning of solar related equipment\'s. Actively involved in project right from DPR preparation to implementation including supply chain activities. Process oriented, poised to tackle the multifaceted challenges of rapidly changing corporate circumstance.
Experience
Ra Specialist
Apr 2025 — Present · Pune, IN
Education
St.Joseph engineering college,mangalore
Master's degree, power electronics
2013 — 2015
Alvas Institute of Engineering and Technology, MOODBIDRI
Bachelor's degree, electronics and communications engineering
2009 — 2013
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