As a new generation medical device company, we believe in the power of working together to make a meaningful and positive difference. Applied Medical is committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth. We are dedicated to creating an environment where team members of diverse backgrounds are valued, challenged and acknowledged. Applied Medical’s products have been serving the Japanese market for over 20 years. In order to continue to build sustainable Japanese partnerships so we can serve the evolving needs of the Japanese health system, we are investing in hiring Regulatory and Quality team members.
The Director of Regulatory Affairs and Quality Assurance will be responsible for overseeing and ensuring compliance to RA, QS and QA requirements in Japan for Applied Medical products. The person in this role will also be expected to develop the local regulatory and quality system strategies and to implement plans according to the pre-defined timelines to support company objectives. The Director of RA and QA may manage and/or provide input into the department’s overall budget and oversees and manages RAQA staff resources and/or outsourced RAQA services.
Other duties and responsibilities
Knowledge, skills and abilities
-With degree of physics, chemistry, metal, electric, engineering, mechanical, information, biology, pharmacy, medical or dental
-Minimum 5 year of experience in quality assurance or safety control
-Completed lecture by MHW
4-year college degree or equivalent degree of physics, chemistry, metal, electric, engineering, mechanic, information, biology, pharmacy, medical or dental
Minimum 8 years of working in a combination of QA, SA, and RA role and/or overseeing team members in these roles.
Applied offers benefits package following Japanese labor laws