RA specialist

【求人No NJB2360931】
The roles of RA specialist are product submission and related quality and safety tasks. He/she will be responsible for from new devices and change control of the certified devices and communicate with Israeli teams （RA R D and relevant section） and other Japan teams.

Responsibilities
・ Product submission for Class II ・ III
・ FMR and QMS conformity investigation
・ License maintenance
・ Communication / negotiation to authorities
・ Communication with other teams for PMD Act such for promotion code etc
・ Communication to contracted consultants
・ Support QA and PMS activities
・ Support other teams

Background
Alma Lasers Ltd. based in Israel has started business for aesthetic laser devices in 1999. Now Alma Lasers Ltd. is expanding regional offices.
In terms of Alma Lasers Japan we have established in October 2023. We are still new and small and aiming to expand business in Japan.

Requirements
・ Knowledge of PMD Act （including QMS GVP Sales license and Repairing license Promotion codes preferable）
・ 3 year experience （Laser device preferred）
・ Bachelor’s degree or above （Science background preferred）
・ Business level English in advantage
・ Knowledge of Laser devices Electrical Safety Law Radio Act in advantage

Competency
・ Ability to communicate across teams
・ Ability to logically organize information
・ Interested in aesthetic devices and industry
・ Good business manners
・ Open proactive teamwork challenge and harmonization mind set