Key Facts

Remote From:

Japan

Category: Regulatory Affairs Manager

Full time

English, Japanese

Hard Skills

Regulatory Compliance Medical Devices NAMD

Other Skills

•
Communication
•
Teamwork

Roles & Responsibilities

Proficiency in native-level Japanese and English
Experience in medical device regulatory affairs
Good experience in Class III and IV medical devices
Experience with IVDs and/or SaMD is a plus

Requirements:

Lead the development and implementation of regulatory strategies for Class III and IV medical devices and IVDs
Manage end-to-end product registration with internal teams, consultants, and health authorities
Deliver regulatory projects and solutions across regional client portfolios
Monitor Japan's regulatory changes and support business growth initiatives

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

Human Resources, Staffing & Recruiting

About Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

➡️ HERE IS WHAT WE DO We specialize in searching for and recruiting top talent in the Pharmaceutical and Medical Device Industry in Japan (JPAC) and Asia (APAC) via our Japan and Singapore offices. ➡️ HOW DO WE GET THINGS DONE With nearly two decades of recruitment experience in the Pharmaceutical Industry in Japan and Asia, we have the client-relationship expertise, knowledge, persistence, dedication, and diligence to ensure even the most challenging recruitment searches are successful. ➡️ FOR HIRING MANAGERS Through our extensive contacts with the best, brightest, and most well-prepared candidates in the market, combined with the ability to fully understand our clients' needs, we can quickly provide the perfect solution to your requirements. ➡️ FOR JOB SEEKERS We take the time to listen, understand and present opportunities to you when you are ready. ➡️ WHERE HAVE YOU SEEN US Since 2006, Philip has been writing a monthly column for Pharma Japan. He has also been published in Life Science Leader, The Fordyce Letter and Biosimilar Development. ➡️ WHAT OTHERS SAY "Philip has exceptional knowledge of the Japanese Pharmaceutical Industry. Philip is also dedicated to advancing global business leaders’ knowledge and applied skills through his insightful articles. I have found the articles beneficial in both the business environment and as excellent discussion topics as part of the International Management course I teach at the University of Texas. I highly recommend Philip to support a company's efforts to advance their firm with a "Global Mindset" staff and practices". Scott Manning, Lecturer at San Diego State University and former Country Manager of Alcon Japan "Philip is extremely knowledgeable of the Japanese Pharma Industry and his articles are always very intriguing. He is certainly a person that can identify talent and professionals that could grow and add value to the hiring company" Masaki Nakanishi, Director of Business Development at AnGes, Inc.

Company type: TPE

Industry: Human Resources, Staffing & Recruiting

Founded: 2018

Company size: 11 - 50

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Job description

Lead the development and implementation of regulatory strategies for Class III and IV medical devices and IVDs. Specialized in identifying opportunities, delivering effective regulatory solutions, and ensuring timely project execution

Plan and implement regulatory strategies for Class III/IV medical devices, IVDs, and SaMDs.
Manage end-to-end product registration with internal teams, consultants, and health authorities.
Deliver regulatory projects and solutions across regional client portfolios.
Support proposal development and project evaluations (e.g., RFPs).
Serve as Japan regulatory SME for medical devices; IVD/SaMD expertise preferred.
Scale operations to support multiple projects and clients efficiently.
Train internal teams, especially India-based staff, on document preparation in English.
Set up robust translation processes for Japan regulatory submissions.
Review and submit regulatory documents; follow up with Japanese authorities until approval.
Monitor Japan's regulatory changes and support business growth initiatives.

Requirements

Proficiency (speaking and writing) in Language: Good command in native-level Japanese and English.
Experience inMedical Device, with experience in a global regulatory affairs role includingregulatory strategy, planning and execution for the new devices in the country.
Exposure or experience in QMS & Vigilance is plus point.
Good experience in Class III and Class IV Medicaldevices. The same for IVDs is desired.
Experience and/or Exposure with SaMD would be anadditional advantage.