Job Information
Stryker Senior Specialist, Regulatory Affairs in Tokyo, Japan
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
The Job's Mission
Under minimum supervision by Manager and Lead Specialist, he/she understands the laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks.
マネジャー、リードスペシャリストの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。
Key Activities & Accountabilities
Responsibilities of this job is the appropriate execution of approval apprications/notifications for medical devices which Stryker Japan K.K. manufactures and distribute. The duties are as follows:
Manufacturing and distribution/certification approval, notifications (including planning, collecting data, and PMDA/NB query correspondence)
Maintenance of approvals and certifications (Change control and periodical renewal)
QMS compliance inspection applications
Insurance listing applications (Creation of insurance listing application forms)
当社が製造販売する医療機器に係る下記を中心とした薬事申請業務の適切な履行を職責とする。
製造販売承認／認証申請、届出（計画立案、資料取集、PMDA／NB 照会対応）
承認／認証の維持管理業務（変更管理、定期更新）
QMS適合性調査申請
保険収載業務（保険適用希望書作成等）
Education
Language Skills (he/she is able to read and write English)
He/she has an ability to write the business documents
英語による文語でのコミュニケーションが実施できる。
ビジネス文書を書くスキルがある。
Experience
3+ years of experience of medical device (Class I to IV) application approvals
Good communications skills and project management skills
Preferred if he/she has knowledge/experience in Vascular products
医療機器（クラスＩ～ＩＶ）の薬事申請における３年程度の実務経験
コミュニケーションスキル、プロジェクトマネジメントスキル
Vascularに関する知識・経験があれば望ましい
Competencies
Not only high level of expertise required to the job, he/she needs to show a good communication skill in the organization. He/she can utilize the skill and communicate efficiently with internal related sections such as QC, WA, Sales & Marketing, Operations, Customer Care and etc.
He/she needs to have integrity and action-oriented mindset.
業務に必要な専門性のみならず、組織の中で、円滑にコミュニケーションが取れる人材。社内関連部門（薬事、品質保証、品質管理、営業、マーケティング、オペレーション、カスタマーケア等）との良好かつ円滑なコミュニケーションが実施できる。
誠実な対応、率先して行動できる人材
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.