j
joshuu8

Joshua

@joshuu8

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

États-Unis
Anglais, Français
Certaines informations sont présentées en anglais.
À propos de moi
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.... Plus d’infos

Compétences

j
joshuu8
Joshua
hors ligne • 
Temps de réponse moyen de 4 heures

Voir mes services

Conformité environnementale
I will do fda 510k eu mdr ivdr mhra sfda medical device compliance
De40 $US / projetPlus de détails
Entreprises et contrats commerciaux
I will help with fda 510k ce marking eu mdr ivdr medical device compliance
De50 $US / projetPlus de détails

Expérience professionnelle

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