Jobs in Japan
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
Johnson & JohnsonThis job posting was originally in Japanese. The English version is automatically translated. Please visit the company site for the most accurate information.
Johnson & Johnson MedTech operates across multiple business areas, including Orthopaedics, Surgery, Electrophysiology, and Neurovascular. This position is for a regulatory affairs professional in the Orthopaedics business and reports to the RA Manager of the relevant business unit. In addition to carrying out regulatory affairs work in the orthopaedics field, you will work with team members on activities and tasks to prepare for the planned separation in the future. This is a valuable opportunity to help build the organization during a period of transformation and gain diverse experience. You will support the achievement of business objectives by planning, preparing, and executing the regulatory actions required to align with the company’s business strategy. You will develop regulatory strategies for assigned projects, such as new product introductions, and carry out regulatory submissions while engaging overseas manufacturers and other stakeholders to obtain their support. You will also negotiate and collaborate with review bodies such as the PMDA and with government organizations to secure approvals promptly and reliably. To ensure the continued stable supply of products after launch, or to discontinue their supply, you will work with relevant stakeholders and complete the necessary internal processes and regulatory procedures in accordance with applicable laws, regulations, and company policies, including post-market change-control procedures. You will conduct advertising reviews and respond to requests and inquiries from overseas manufacturers and internal stakeholders. You will also handle compliance-related work, primarily concerning the Pharmaceuticals and Medical Devices Act. Johnson & Johnson announced plans to separate its Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Johnson & Johnson announced plans to separate its Orthopaedics business and establish an independent company operating as DePuy Synthes. The separation is expected to be completed within 18 to 24 months, subject to the fulfillment of the necessary conditions. Following completion of the separation, you will be employed by DePuy Synthes and covered by its employment framework, programs, policies, and benefits. DePuy Synthes is expected to provide further details at an appropriate time.
- At least 3–5 years of regulatory affairs experience with medical devices (any class) or pharmaceuticals, including in vitro diagnostic products, or equivalent work experience in quality assurance or research and development. - English reading and writing skills, with no reluctance to work in English.
- A strong desire to improve and learn, as daily work may involve reading product development documents in English and communicating in English with overseas manufacturers. - Experience leading PMDA face-to-face consultations or simplified consultations. - Ability to support and assist others and team members across regulatory affairs work in general. - A master’s degree or higher in engineering, science, agriculture, pharmacy, medicine, dentistry, life sciences, public health, or a related field.
