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Karthik Hoskere

• Managing the Regulatory Affairs function for a significant business segment • Expert knowledge of U.S FDA, Health Canada and the... | Copenhagen, Capital Region, Denmark

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Karthik Hoskere’s Location Copenhagen, Capital Region, Denmark

Karthik Hoskere’s Expertise • Managing the Regulatory Affairs function for a significant business segment • Expert knowledge of U.S FDA, Health Canada and the European Medical Device Regulation • Developing global regulatory strategies for new and modified medical devices. • Preparing submission package for obtaining regulatory approval worldwide • Proven track record of obtaining Inmetro, CFDA, KFDA, SFDA approvals • Preparing Technical File and obtaining CE Marking for Class II devices • Tracking global regulatory changes and perform impact assessment • Facing Notified Body audits and FDA inspections • Knowledgeable on 21 CFR Part 820 regulations and ISO 13485 standard • Preparing and submitting Product reports for Radiological devices • Developing internal regulatory procedure

Karthik Hoskere’s Current Industry 3shape

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Work Experience

3shape

Principal Regulatory Affairs Specialist

Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Philips

Regulatory Affairs

Wed May 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Wipro

Project Lead

Mon Nov 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed May 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)

Larsen And Toubro

Assistant Manager

Sun Oct 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Cimnet Systems

CAM Engineer

Fri Jul 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Sep 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)

Bpl

Design Engineer

Tue Jun 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jun 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

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Karthik Hoskere Email Addresses

[email protected] Email

Karthik Hoskere Phone Number

No phone number available. Phone number

FAQ About Karthik Hoskere

Karthik Hoskere is located at
Copenhagen, Capital Region, Denmark

Karthik Hoskere is a
• Managing the Regulatory Affairs function for a significant business segment • Expert knowledge of U.S FDA, Health Canada and the European Medical Device Regulation • Developing global regulatory strategies for new and modified medical devices. • Preparing submission package for obtaining regulatory approval worldwide • Proven track record of obtaining Inmetro, CFDA, KFDA, SFDA approvals • Preparing Technical File and obtaining CE Marking for Class II devices • Tracking global regulatory changes and perform impact assessment • Facing Notified Body audits and FDA inspections • Knowledgeable on 21 CFR Part 820 regulations and ISO 13485 standard • Preparing and submitting Product reports for Radiological devices • Developing internal regulatory procedure 3shape

Karthik Hoskere currently works in the
3shape

Karthik Hoskere specializes in
• Managing the Regulatory Affairs function for a significant business segment • Expert knowledge of U.S FDA, Health Canada and the European Medical Device Regulation • Developing global regulatory strategies for new and modified medical devices. • Preparing submission package for obtaining regulatory approval worldwide • Proven track record of obtaining Inmetro, CFDA, KFDA, SFDA approvals • Preparing Technical File and obtaining CE Marking for Class II devices • Tracking global regulatory changes and perform impact assessment • Facing Notified Body audits and FDA inspections • Knowledgeable on 21 CFR Part 820 regulations and ISO 13485 standard • Preparing and submitting Product reports for Radiological devices • Developing internal regulatory procedure