Eric Chen
EC

Eric Chen

Linkedin Profile
Director Regulatory Affairs, Global Regulatory Services at Abbott | Fulton, Maryland, United States
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About Eric Chen

  • Eric Chen serves as the Director of Regulatory Affairs within Abbott’s Global Regulatory Services, where he plays a pivotal role in shaping the regulatory landscape for the company’s innovative medical device portfolio. With over 20 years of experience in the medical device industry, Eric has...
    Eric Chen serves as the Director of Regulatory Affairs within Abbott’s Global Regulatory Services, where he plays a pivotal role in shaping the regulatory landscape for the company’s innovative medical device portfolio. With over 20 years of experience in the medical device industry, Eric has cultivated a deep expertise in cardiovascular devices, particularly in the realm of mechanical circulatory support systems, as well as neuromodulation technologies like deep brain stimulation. His extensive background also encompasses the development of orphan products and pediatric devices, making him a versatile leader in navigating complex regulatory pathways. In his current role, Eric is instrumental in managing regulatory strategies that align with Abbott’s commitment to advancing healthcare solutions. He leads key projects that involve the submission and approval processes for Premarket Approvals (PMAs) and Humanitarian Use Devices (HUDs), ensuring compliance with FDA regulations while advocating for innovative therapies that address rare diseases. His unique combination of clinical and regulatory experience allows him to bridge the gap between scientific innovation and regulatory requirements, fostering collaboration across multidisciplinary teams. Eric’s leadership extends beyond regulatory submissions; he actively engages in policy development and advocacy efforts that shape the future of medical device regulations. His proficiency in biomaterials and life sciences, coupled with his strategic vision, positions him as a respected thought leader in the industry. As Abbott continues to push the boundaries of medical technology, Eric Chen remains at the forefront, driving initiatives that not only meet regulatory standards but also enhance patient outcomes globally.
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  • Eric Chen Work

    • Director Regulatory Affairs, Global Regulatory Services at Abbott in February 2019 to Present
    • Director, Pediatric Device Consortia Grants Program at FDA in October 2016 to February 2019
    • Director, Humanitarian Use Device Program at FDA in February 2010 to February 2019
  • Eric Chen Skills

    • Medical DevicesBiomedical EngineeringClinical Trials
      FDARegulatory AffairsBiomaterialsISO 13485Program ManagementVentricular Assist DevicesBiotechnologyHDEsHumanitarian Use DevicesCardiovascular DevicesPolicyRare DiseasesHealthcareClinical ResearchHospitalsMedicineLife SciencesResearchPMAsIDEsLeadershipManagement

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  • About Eric Chen's Current Company

  • Frequently Asked Questions about Eric Chen

    • What is Eric Chen email address?
      Email Eric Chen at e***n@abbott.com. This email is the most updated Eric Chen email found in 2024.
    • How to contact Eric Chen?
      To contact Eric Chen send an email to e***n@abbott.com.
    • What company does Eric Chen work for?
      Eric Chen works for Abbott
    • What is Eric Chen's role at Abbott?
      Eric Chen is Director Regulatory Affairs, Global Regulatory Services
    • What is Eric Chen's Phone Number?
      Eric Chen's phone (301) ***-*714
    • What industry does Eric Chen work in?
      Eric Chen works in the Software Development industry.

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