Let’s Talk About The Team And You

The RA Global team is located at various offices around the world and is responsible for compliance with multiple regulatory frameworks as it relates to design, development and manufacture of products as well as services which meet our customer’s requirements.

Based in Tokyo, Japan (open to hybrid flexibility), you will manage and execute the planning, development and implementation of RA strategies for new offerings (i.e. hardware, software, services) and new business channels in Japan. You  will also provide regional regulatory support to operational activities for Japan, including label review. You will be part of and collaborate closely with other global and regional RA teams.

Let’s Talk About Responsibilities

GVP Activities (including but not limited to complaint handling and adverse event reporting to competent authorities):

• Obtain information from external and internal sources as well as assess the necessity of action locally and abroad.
• Prepare and file with corresponding authorities (i.e. PMDA, if needed).
• Prepare yearly reporting as well as monthly website/conference check list and delegation, if needed.
• Prepare yearly PMDA Safety contribution and MHLW monthly manufacturing statistics survey
• Be responsible for all documents related to GVP.

QA Activities:

• Maintain appropriate licenses to operate (i.e. MAH, sales, foreign manufacturer, label manufacturer, repair)
• Support QMS as well as internal/external audits/inspections.
• Responsible for Product Master Files as well as local IFUs, local labels, manuals, work instructions and records internal and external.

RA activities:

• Participate in regional cross functional teams, by providing regulatory strategy, timelines and deliverables; working closely with clinical, marketing, and commercial functions to assure appropriate requirements are defined for the specific device/channel, including claims and target patient population within each market.
• Manage the continuance of regulatory compliance (particularly post market) of existing ResMed products, including software as a medical device in selected region(s).
• Responsible for submissions for local regulatory authorities and their lifecycles.
• Review and provide feedback on country-specific advertising, including product claims as well as overall direct to consumer content.
• Region specific due diligence on new projects, including acquisitions.
• Support initiatives related to regional entity creations (including eCommerce).
• Ensure timely, professional and proactive communications with internal customers to ensure transparency of the regulatory strategic plans, updates/changes and impact to projected timeframes.
• Monitor and maintain high level of awareness on external standards that will influence our business through internal and external networks; not limited to ‘Act on Securing Quality, Efficacy and Safety Products Including Pharmaceuticals and Medical Devices’, ‘Medical Practitioners’ Act’, ‘Radio Act’, ‘Code of Fair Practices in the Advertising of Drug and Related Product’.
• Accurately and timely share and recommended solutions on any potentially significant changes that will impact the business.
• Ability to lead communication with local regulators, not limited to PMDA, Notified Bodies and local prefefactures.
• Serve as an MAH controller as a General Manager and/or Post-Marketing Safety Controller

Let’s Talk Qualifications And Experience

• Min Degree in a Lifescience or Engineering related discipline.
• Min 5-8 years’ regulatory experience in a regional role handling regulatory work for medical devices in Japan and other similar entities or for other regulated products, including consumer products.
• Experience in review of marketing materials for medical devices or other regulated products.
• Strong interpersonal communication skills in English.
• Ability to prioritize workload and work independently by being resourceful.
• Ability to work with a multifunctional team by maintaining good relationships with people, focusing on team work and support. This is the most respected value in our company culture.
• Influential leadership.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!