Connect with Yvonne
• Email Me or Poke Me
• Interview Me
• Send Group Invite
• Add To Favorites
• Block This Member
• Send Friend Request
Uploads
Upload Content | Show More  
Connections
more-->  
Recent Visitors
more-->  
More Members
more-->  
Q&A With Yvonne Doswell

(interview me)
Yvonne Doswell
Senior Scientist Regulatory Affairs, Sysmex America, Inc.
Location: Lithonia, GA United States
Joined: Jun 26th, 2023
About   (request update)
Health care professional with over 20 years' experience in working in fast-paced clinical environments demanding strong organizational, technical, and interpersonal skills.
Solid knowledge of fundamental epidemiological methods; broad knowledge of clinical trials: structure and components and writing standard operation procedures.
Excellent communicator with strong analytical and problem-solving skills; excellent organization and time management skills; ability to work both independently and as part of a team.
Managerial skills in team leadership, budget development, project management, and strategic planning.
Experience in developing quality systems for performing laboratory testing that provide accurate and reliable patient test results within CLIA, CAP, OSHA and JACHO regulations.
Education   (request update)
Norfolk State University class of 1984
Undergrad Major: Medical Technology
Campus Organization:
Delta Sigma Theta
- College Not Listed - class of 2001
Grad Major: Business Administration
Experience
I currently work with Sysmex America, Inc. as Senior Scientist Regulatory Affairs
I have 4 years of experience working in the Healthcare, Other industry.
Senior Scientist Regulatory Affairs | Sysmex America, Inc.
From September 2019 to Current • 7 year(s)
 Assess regulatory pathways for new product platforms and product modifications; develop regulatory strategies and tactical plans for submissions to FDA, Health Canada and other regulatory agencies as needed. Write, review, and assemble high quality regulatory submissions to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards. Provide strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies. Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results. Monitor scientific and clinical activity related to assigned product lines and projects in order to develop sound, clinically relevant content to support regulatory submissions and responses to regulatory inquiries. Communicate with regulatory Agencies and attend Agency meetings as needed to assist the Regulatory Affairs Director. Review and interpret existing and new external standards and regulatory requirements as they relate to Sysmex products and processes to ensure regulatory compliance US and Canadian Medical Device regulations and guidelines. Conduct on-going surveillance to identify information on product clearances/approvals and rejections to develop best practices. Keep current on FDA guidance and rulemaking to anticipate regulatory changes that may impact future products and submissions. Develop and mentor junior Regulatory staff members. Perform regulatory administrative activities and other duties as needed.
My Groups
Invite Me To A Group
Guestbook Comments
It's my pleasure to have you join, us as a new or seasoned member. May you have an amazing, blessed and marvelous day
Tagged by Ralph White on 10/01/2023  
more-->
Member Login
Email:
 Password:

Not a Member? Sign Up - It's FREE
You'll receive access to our Newsletter, Scholarships, HBCU Profiles, Jobs, Internships, Mentors, Member Profiles and more!
Upload Photo:
First Name:
 Last Name:
Email:
 Password:
Location:
College:
Major:
Graduating Class:
Featured Jobs & Internships

Arizona State University
NETWORK ENGINEER in Tempe, AZ

Arizona State University
SENIOR NETWORK ENGINEER in Tempe, AZ

State of Connecticut - Department of Correction, Unified School District #1
DOC State School Teacher - Multiple Endorsements & Facilities - State of Connecticut - Accepting applications through 1/21/26 in Various locations in CT, CT

State of Connecticut - Department of Correction, Unified School District #1
Advanced Manufacturing Vocational Instructor - State of Connecticut - Accepting applications through 2/2/26 in Various locations in , CT

State of Connecticut - Department of Correction, Unified School District #1
Hospitality Vocational Instructor - State of Connecticut (Accepting applications through 2/2/26) in Various locations in , CT

Hunter College
Assistant or Associate Professor - Department of Physical Therapy (DPT), Brookdale Campus in New York City, NY

State of Connecticut
Community Clinician in Middletown, CT

The Chapin School
Middle School Class 5 Humanities Teacher and Advisor in New York, NY

State of Connecticut, Executive Branch
Correctional General Maintenance Officer in Multiple; See Posting, CT

State of Connecticut Department of Veterans Affairs
Buildings And Grounds Patrol Officer in Rocky HIll, CT

Meals on Wheels America
Graphic Design Senior Manager in Arlington, VA

Meals on Wheels America
Operations Administrative Assistant - 30 hours a week in Arlington, VA

Meals on Wheels America
Strategy Implementation & Integration Senior Director in Arlington, VA

Frank
Social Media & Lifecycle Marketing Specialist in Remote, US

State of Connecticut, Executive Branch
Advanced Professional Counselor - Apply by 2/2/2026 in Norwich, CT
Subscribe!
  • View Past Email Announcements
  • View Past Weekly E-Newsletters
    • HBCU CONNECT
    Follow Us!