j
joshuu8

Joshua

@joshuu8

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

Estados Unidos
Inglês, Francês
Algumas informações são exibidas no idioma inglês.
Sobre mim
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.... Saiba mais

Habilidades

j
joshuu8
Joshua
offline • 
Tempo médio de resposta: 4 horas

Conheça meus serviços

Conformidade ambiental
I will do fda 510k eu mdr ivdr mhra sfda medical device compliance
A partir deUS$ 40 /projetoMais detalhes
Negócios e contratos comerciais
I will help with fda 510k ce marking eu mdr ivdr medical device compliance
A partir deUS$ 50 /projetoMais detalhes

Experiência profissional

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