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joshuu8

Joshua

@joshuu8

Medical Device Regulatory Affairs Specialist, FDA, EU MDR, IVDR, MHRA, SFDA

United States
English, French
About me
Are you struggling to get your medical device approved in the US, EU, or UK? I help manufacturers, startups, and distributors successfully navigate FDA 510(k), CE Marking (EU MDR/IVDR), and UKCA compliance without delays, rejections, or costly mistakes. With hands on experience in regulatory documentation and submission strategy, I support you with: 510(k) submission preparation EU MDR / IVDR Technical Documentation Clinical Evaluation Reports Risk Management (ISO 14971) ISO 13485 I focus on accuracy, compliance, and fast turnaround, ensuring your product meets global regulatory standards.... Read more

Skills

j
joshuu8
Joshua
Offline • 
Average response time: 4 hours

See my services

Environmental Compliance
I will do fda 510k eu mdr ivdr mhra sfda medical device compliance
From$40 / projectMore details
Business & Commercial Contracts
I will help with fda 510k ce marking eu mdr ivdr medical device compliance
From$50 / projectMore details

Work experience

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Jan 2024 - Present • 2 yrs 4 mos

Assisted medical device companies with FDA and EU MDR compliance Prepared technical documentation Supported CE Marking submissions Conducted regulatory gap analysis Prepared regulatory strategies