Lori Hays

Lori Hays Email and Phone Number

Vice President of Regulatory @ Cerapedics Inc.
Lori Hays's Location
San Diego Metropolitan Area, United States, United States
Lori Hays's Contact Details

Lori Hays personal email

n/a

Lori Hays phone numbers

About Lori Hays

Established Regulatory Affairs executive with pharmaceutical, medical device, biologic and combination product experience. Able to work collaboratively with business partners to navigate regulatory and quality obstacles and provide global strategic guidance in a variety of areas. Skilled in navigating and implementing Medical Devices, Biologics, Pharmaceutical and Combination Product regulations from the US, Europe, Canada and APAC. Experience with full product lifecycle quality and regulatory activities, including formulation and design control, quality system set-up, establishing strategic regulatory pathways incorporating accelerated approval options, authoring complex regulatory submissions and negotiating pathways with Authorities, and post-market product management.Achievements include 15+ Investigational product approvals (including IDEs, ITAs, INDs and CTAs), 150+ PMA Supplements, 25+ 510(k)s, 2 NDAs and 40+ International Marketing Authorizations.

Lori Hays's Current Company Details
Cerapedics Inc.

Cerapedics Inc.

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Vice President of Regulatory
Lori Hays Work Experience Details
  • Cerapedics Inc.
    Vice President Of Regulatory
    Cerapedics Inc. Jul 2022 - Present
    Westminster, Co, Us
    View
  • Viacyte
    Director Of Regulatory Affairs
    Viacyte Jun 2021 - Jun 2022
    San Diego, Ca, Us
    View
  • Pinnacle Biologics, Inc.
    Sr. Director Of Regulatory Affairs And Quality Assurance
    Pinnacle Biologics, Inc. Nov 2014 - Apr 2021
    Bannockburn, Illinois, Us
    View
  • Merz North America
    Director Of Regulatory Affairs
    Merz North America Apr 2007 - Oct 2014
    Raleigh, Nc, Us
    View
  • Teleflex Medical
    Director Of Regulatory Affairs
    Teleflex Medical Sep 2005 - Apr 2007
    Wayne, Pa, Us
    View
  • Sage Products
    Regulatory Affairs Manager
    Sage Products Oct 1999 - Sep 2005
    Cary, Il, Us
    View
  • Heyer-Schulte
    Regulatory Affairs Project Manager
    Heyer-Schulte Jan 1997 - Aug 1999

Lori Hays Skills

Regulatory Affairs Fda Capa Design Control Medical Devices Regulatory Submissions Regulatory Requirements Pharmaceutical Industry Quality System Validation Gmp Ce Marking Change Control Pma Medical Device Directive Quality Auditing 21 Cfr Iso 13485 V&v

Lori Hays Education Details

  • University Of Wisconsin-Madison
    University Of Wisconsin-Madison
    Medical Technology (In-Vitro Diagnostics)
  • Regulatory Affairs Professional Society
    Regulatory Affairs Professional Society
    Regulatory Affairs Certification (Rac)

Frequently Asked Questions about Lori Hays

What company does Lori Hays work for?

Lori Hays works for Cerapedics Inc.

What is Lori Hays's role at the current company?

Lori Hays's current role is Vice President of Regulatory.

What is Lori Hays's email address?

Lori Hays's email address is ha****@****ics.com

What is Lori Hays's direct phone number?

Lori Hays's direct phone number is (847) 283*****

What schools did Lori Hays attend?

Lori Hays attended University Of Wisconsin-Madison, Regulatory Affairs Professional Society.

What skills is Lori Hays known for?

Lori Hays has skills like Regulatory Affairs, Fda, Capa, Design Control, Medical Devices, Regulatory Submissions, Regulatory Requirements, Pharmaceutical Industry, Quality System, Validation, Gmp, Ce Marking.

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