Helen J.
Regulatory Affairs consultant for medical device design control and validation
Buffalo,
United States
Global rank:
77,505
/
134,918
Skill pts: 0
CAD Design
Design and Analysis
Design Validation Test
Product Design and Development
Product Validation and Verification
About
Experienced Regulatory Affairs Consultant with a demonstrated history of working in Medical devices, Drugs, Biologics, and Combination products. Skilled in Regulatory Affairs, Quality Assurance, Clinical trials, New Drug Application (NDA), Investigational Drug Application (IND), Risk Assessment, Biologic License Application (BLA), and Consulting.
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Experience
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Regulatory Affairs consultant
Elexes Medical Consulting · Full-time
Jan 2020 –
Present
6 yrs 5 mos
undefined, United States
Design Verification and Validation of medical devices.
Product development, Regulation and Quality consulting.
Stats
0 followers, 0 following
Joined: October 15, 2020
Area of Expertise
Languages
English Native or bilingual proficiency
Location
Buffalo, WY, United States