j
joshuu8

Joshua

@joshuu8

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

Stati Uniti
Inglese, Francese
Alcune informazioni sono riportate in lingua inglese.
Chi sono
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.... Continua a leggere

Competenze

j
joshuu8
Joshua
offline • 
Tempo di risposta medio: 4 ore

Consulta i miei servizi

Conformità ambientale
I will do fda 510k eu mdr ivdr mhra sfda medical device compliance
A partire da40 USD / progettoMaggiori dettagli
Contratti aziendali e commerciali
I will help with fda 510k ce marking eu mdr ivdr medical device compliance
A partire da50 USD / progettoMaggiori dettagli

Esperienza lavorativa

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