Work Flexibility: Hybrid or Onsite

The Job's Mission

Stryker Japan is the first market comer in the Japanese R-SUD market, and this role is expected to expedite the right awareness of R-SUD and to contribute a rapid market penetration of them in Japan through regulatory affairs activities such as obtaining new product approvals and a reimbursement pricing or other related tasks.

Key Activities & Accountabilities

Regulatory Activity:

Responsibilities of this job is the appropriate execution of approval applications/notifications for R-SUD which Stryker Sustainability Solutions designs, remanufactures and distributes. The duties are as follows:

• Obtains a marketing approval, filing a notification (including making a submission strategy, collecting appropriate data, and PMDA query correspondence)
• Maintenance of approvals and certifications (change control, monitoring OM devices and periodical renewal)
• Facilitates QMS compliance inspection for all sites (collecting QMS documents, supporting Quality team and PMDA query correspondence)
• Insurance listing applications (creating a reimbursement request form and negotiating with MHLW for the pricing)
• PMDA consultation

Communication:

• Establishes strong relationships with PMDA and MHLW and manages these relationships proactively
• Establishes good working relationships with Stryker staff
• Ensures the ability to represent a project that he/she is in charge in monthly & quarterly reviews to stakeholders both internal and external to Stryker Japan

Education

• Language Skills (he/she is able to speak, read and write English)
• He/she has an ability to write the business documents

Experience

• 4+ years of experience working in Regulatory affairs in obtaining marketing approvals of Class I to II medical devices
• Preferably experience working on a QMS submission
• Good communications skills and project management skills

Competencies

• High communication skills to carry one’s points in constructive and cooperative manners with internal and external stake holders
• Self-motivated for leading projects and tackling issues
• Ability to enjoy facing the new challenges to breakthrough “Status-quo”
• Foresees a potential risk of a regulatory submission project and manages a risk mitigation in obtaining the approval
• He/she needs to have integrity and action-oriented mindset.

Comments

• Please describe in detail the history of approval / certification application and the role you played in your resume.
• Travel Percentage: Low frequency of traveling or in cities other than the office

Travel Percentage: None