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FDA 510K regulatory affairs

A startup medical device company is looking for a regulatory affairs specialist experienced in the cardiac diagnosis market space. The primary task requires extraction of the user requirements from the FDA 510K summary report. The user requirements will then be used in our product development plan life cycle. The second task is to establish substantial equivalency through comparison of our product specifications

The task applies to Class II B hardware devices and Software as Medical Device (SaMD) projects.

Skills: Medical

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About the Employer:
( 0 reviews ) Belmont, United States

Project ID: #26412457

5 freelancers are bidding on average $52/hour for this job

chraheelbhatti

I'm experienced research writer with 06 yrs of experience in the field. I have done multiple successful projects on this. I can help.

$50 USD / hour
(1 Review)
2.7
johnwanjiku

Dear Prospective Client, Upon analyzing the assignment detailsFDA 510K regulatory affairs, I am assured that I will be capable to entire it diligently and professionally on the anticipated date. You are guaranteed; - I More

$50 USD / hour
(1 Review)
1.1
paigop

I am a clinical researcher by profession for over 30+ years and worked in regulatory environments for both biopharmaceutical and medical device companies. I have recently done regulatory submission for a blutooth enabl More

$61 USD / hour
(0 Reviews)
0.0
Parastoosaberi94

Hello, I'm a recent medical graduate currently catching my breath and working from home. I think I can live up to your expectations and look forward to hear from you. Thanks Parastoo

$50 USD / hour
(0 Reviews)
0.0
asifmirzza

Hi, I am a Certified Medical Device Professional by BSI, with 5 years of experience in Medical devices as a Regulatory Affairs Consultant, specializing in US FDA and EU MDR 2017/745. My work as a RA Consultant involv More

$50 USD / hour
(0 Reviews)
0.0