Abhi Mukherjee

Abhi Mukherjee Email and Phone Number

Head of Quality and Regulatory Affairs @ Laza Medical
United States
Abhi Mukherjee's Location
United States, United States
Abhi Mukherjee's Contact Details

Abhi Mukherjee personal email

About Abhi Mukherjee

Horizon Consulting, LLC provides regulatory consulting services to medical device, pharmaceutical and biotech companies. Whether you are an upcoming startup or a global establishment, Horizon Consulting can help your company deploy the best strategic regulatory pathway to get your product to the market and keep it there. Our core expertise includes Regulatory Strategy, Submission & Approval, Post-Market Compliance, and Business Development. We have worked on several domestic and international regulatory submissions for a number of companies including the first 510(k) cleared by FDA for a machine learning application for a medical imaging platform and global regulatory approval strategy for a robotic surgery platform. Prior to starting Horizon, I served in both technical and senior leadership capacities in Regulatory Affairs at Verb Surgical (joint venture between Johnson & Johnson and Google), Ethicon and Stryker. I am passionate about helping introduce new medical technologies to the market so that doctors and patients have access to better healthcare. I love working in regulatory affairs as it gives me the opportunity to work closely with the FDA and other international regulatory bodies to bring innovative devices to the market.

Abhi Mukherjee's Current Company Details
Laza Medical

Laza Medical

View
Head of Quality and Regulatory Affairs
United States
Website:
lazamedical.com
Employees:
31
Abhi Mukherjee Work Experience Details
  • Laza Medical
    Head Of Quality And Regulatory Affairs
    Laza Medical
    United States
  • Laza Medical
    Head Of Quality & Regulatory Affairs
    Laza Medical Jan 2024 - Present
  • Horizon Consulting, Llc
    Founder & Principal Consultant
    Horizon Consulting, Llc Oct 2016 - Feb 2024
    Horizon Consulting, LLC offers regulatory consulting services to medical device, pharmaceutical and biotech companies to help them get innovative products to market and maintain compliance cost-effectively. Our core expertise includes Regulatory Strategy, Submission & Approval, Post-Market Compliance, and Business Development. To learn more visit us at www.horizon-dh.com
  • Verb Surgical Inc.
    Director, Regulatory Affairs
    Verb Surgical Inc. Feb 2019 - Mar 2020
  • Verb Surgical Inc.
    Associate Director Regulatory Affairs
    Verb Surgical Inc. Jun 2017 - Jan 2019
    Led the regulatory approval strategy for Verb Surgical's digital surgery platform that combined the power of robotics, advanced instrumentation, enhanced visualization, connectivity and data analytics into one platform.
  • Cardinal Health
    Director Regulatory Affairs
    Cardinal Health Jul 2015 - Jun 2017
    Dublin, Oh, Us
    Led a team of regulatory professionals working on pre- and post-market projects. Participated in due diligence activities for several business development and M&A projects.
  • Stryker
    Sr. Regulatory Affairs Manager
    Stryker Mar 2013 - Jul 2015
    Kalamazoo, Mi, Us
    Managed a highly engaged team of pre- and post-market regulatory professionals with a proven track record of delivering timely global medical device approvals. Extensive experience in domestic and international regulatory submissions for Class II/ Class III medical devices, post market regulatory functions and due diligence activities for mergers and acquisitions.
  • Stryker
    Regulatory Affairs Manager
    Stryker Nov 2010 - Feb 2013
    Kalamazoo, Mi, Us
  • Ethicon Endo-Surgery
    Senior Regulatory Affairs Associate
    Ethicon Endo-Surgery Nov 2007 - Nov 2010
    Raritan, Nj, Us
  • Stryker Endoscopy
    Standards Engineer
    Stryker Endoscopy Aug 2006 - Oct 2007

Abhi Mukherjee Skills

Medical Devices Iso 13485 Fda Regulatory Affairs Regulatory Submissions Biomedical Engineering Capa Ce Marking Validation Design Control Iso 14971 21 Cfr U.s. Food And Drug Administration V&v Quality System Clinical Trials R&d Pma Medical Device Directive Biotechnology Corrective And Preventive Action

Abhi Mukherjee Education Details

  • The Ohio State University
    The Ohio State University
    Biomedical Engineering
  • Northwestern University - Kellogg School Of Management
    Northwestern University - Kellogg School Of Management
    Regulatory Affairs

Frequently Asked Questions about Abhi Mukherjee

What company does Abhi Mukherjee work for?

Abhi Mukherjee works for Laza Medical

What is Abhi Mukherjee's role at the current company?

Abhi Mukherjee's current role is Head of Quality and Regulatory Affairs.

What is Abhi Mukherjee's email address?

Abhi Mukherjee's email address is ab****@****ail.com

What schools did Abhi Mukherjee attend?

Abhi Mukherjee attended The Ohio State University, Northwestern University - Kellogg School Of Management.

What skills is Abhi Mukherjee known for?

Abhi Mukherjee has skills like Medical Devices, Iso 13485, Fda, Regulatory Affairs, Regulatory Submissions, Biomedical Engineering, Capa, Ce Marking, Validation, Design Control, Iso 14971, 21 Cfr.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.