|職務内容||The company is looking for a Regulatory Affairs (RA) Specialist or Senior specialist based in Tokyo office. The (senior) Specialist is responsible for regulatory work depending on the company regulatory strategy. Preparation of submission documents for regulatory approval and the maintenance for those approved products are some of the main work. The (Senior) Specialist will report to a manager.
【CORE JOB RESPONSIBILITIES】
〇 Create necessary documentations for product submission to Japan market and do the maintenances such as submission of minor change notifications, partial change as needed.
〇 Communicate and/or negotiate with PMDA to obtain regulatory approval for vascular, structural heart, and other cardiovascular devices..
〇 Contribute to defining regulatory strategies for assigned products
〇 Assess product, manufacturing, etc. changes for regulatory impact
〇 Communicate with each business unit RA and manufacturer on assigned products.
〇 Work in a team of 3-4 people.
|応募資格||〇 Have communication skills & to be cooperative
〇 Communication and negotiation with overseas team members (English language) (e-mail, telephone conference)
〇 Class 3-4 regulatory work experience of medical device, preferably with cardiovascular devices
Submission of PMDA applications for new products, partial changes, and minor change notifications. Preferred experience in cardiovascular products.
〇 University Degree in Science or related fields
〇 For senior specialist, minimum 5 years
〇 For specialist, minimum 2 years