Global Medical Device Regulatory Affairs Specialist

NIHON KOHDEN OrangeMed

Santa Ana (CA)

Sur place

USD 80 000 - 95 000

Plein temps

14 jours+

Obtenez une réponse de cet employeur

Votre CV et votre lettre de motivation, adaptés exactement à ce que l’employeur recherche.

Passez les filtres ATS

Résumé du poste

Nihon Kohden OrangeMed is seeking a Regulatory Affairs Specialist to coordinate routine regulatory activities for our global medical device business. You will manage registrations, submissions, and post-market requirements across domestic and international markets, collaborating with internal teams, sales offices, distributors, and regulatory partners.

Ideal candidates have a Bachelor’s degree in a technical field, at least 3 years in Regulatory Affairs for medical devices, and strong writing,

Qualifications

Bachelor’s degree or higher in a technical field and relevant regulatory experience.
Experience with FDA submissions and international regulatory requirements.
Strong documentation, writing, and communication skills.

Responsabilités

Coordinate global product registrations, approvals, and shipping authorizations.
Prepare and assemble regulatory submissions, including FDA 510(k) and international dossiers.
Maintain regulatory records, logs, and submission status across products and markets.
Respond to information requests from FDA and other authorities with SME support.
Monitor regulatory developments and communicate impacts to stakeholders.