Elijah W.

Regulatory Affairs | Medical Devices | Biotechnology

United States of America
English

A board director, global regulation and compliance leader, and industry representative for the FDA Advisory Committee Neurological Devices Panel, recognized for subject matter expertise within the rea...see more

  • Biotech, Pharma & Life Sciences
  • Electrical Equipments & Components

650

/hr
  • Pre-vetted expert
  • Confirmed hourly rate
  • Available on short notice

Experience

Regulatory Affairs Manager

Zimmer Biomet
2 years
Current position
Mar 2021 - Present
• Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products. • Perform research, analys...see more

Adjunct Faculty Instructor

Northeastern University College of Professional Studies
4 years
Current position
Aug 2018 - Present
• Teach Medical Development: A Regulatory Overview. Course analyzes U.S. medical device development and approval requirements.

Industry Representative, FDA Advisory Committee Neurological Devices Panel

FDA
5 years
Apr 2017 - Dec 2021
• Provided recommendations to the FDA Advisory Committee panel in relation to clinical study data to support the safety and effectiveness of Class 3 medical devices and De Novo applicat...see more

Regulatory Affairs Manager

Invacare Corporation
6 years
Apr 2015 - Mar 2021
• Advised on the annual operating plan for Invacare, making recommendations to establish the appropriate funding and resources to meet with business goals. Developed, and managed a top ...see more

Senior Regulatory Affairs Specialist

Stryker
2 years
Feb 2013 - Apr 2015
• Authored ten 510(k) submissions and two Pre-Submissions for orthopedic medical devices. • Managed and successfully implemented FDA Unique Device Identifier (UDI) regulatory and comp...see more

Regulatory Specialist

Rochester Medical
< 1 year
Jan 2012 - Jan 2012
• Authored one 510(k) submission, and updated several CE Technical Files, and Design Dossiers. • Managed regulatory submission, requirements and strategy for new product development. • ...see more

Medical Device Staff Fellow

FDA
< 1 year
Jan 2011 - Jan 2011
• Facilitated the writing of the 2011 Draft Guidance Document on processing and reprocessing of medical devices in health care settings. • Developed a technical report on guidelines an...see more

Research & Development Quality Control Chemist

Perrigo Company plc
1 year
May 2009 - Jul 2010
• Oversaw and managed assembly and publishing of all documents while maintaining adherence to FDA standards and internal requirements

Quality Control Chemist

Medivators
3 years
Sep 2003 - Dec 2006
• Analyzed raw materials and finished products for manufacturing using analytical chemistry techniques.

Industries, roles and expertise

Industry experience

  • Biotech, Pharma & Life Sciences
  • Electrical Equipments & Components

Expertise

  • Leadership
  • Quality System
  • GMP
  • GLP
  • CAPA
  • FDA
  • eCTD
  • CE marking
  • Youth Development
  • Youth Leadership
  • Post Market Surveillance
  • Regulatory Science