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Japanese Regulatory Affairs SME
Job Summary:
We are seeking an experienced and highly knowledgeable Medical Device Regulatory Affairs Consultant with expertise in Japanese medical device regulations. The ideal candidate must be fluent in Japanese and possess in-depth knowledge of Japanese regulatory requirements (PMDA) as well as having direct experience writing authorized rep submissions. This role is critical in ensuring compliance with Japanese regulations for critical care cardiac monitoring devices, particularly those incorporating software and AI elements. The consultant will be responsible for gathering reports, reviewing protocols, and updating submissions to meet Japanese standards, while also working directly with international notified bodies and licensed representatives in the region.
Key Responsibilities:
Qualifications:
Full Time
$83k-107k (estimate)
06/27/2024
07/13/2024
alku.com
ANDOVER, MA
200 - 500
2008
Private
MARK ELDRIDGE
$200M - $500M
Business Services
ALKU is a recruitment agency that offers staffing solutions for SAP, Oracle and Peoplesoft roles.
The following is the career advancement route for Regulatory Affairs Consultant positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Consultant, it can be promoted into senior positions as a Regulatory Affairs Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Consultant. You can explore the career advancement for a Regulatory Affairs Consultant below and select your interested title to get hiring information.