[Heart Recovery]

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Job Description:

The RA staff in this role plans coordinates and executes Regulatory Affairs activities for both new and existing products. Responsibilities include interpreting regulations leading crossfunctional implementation of compliance measures and communicating with health authorities in relation to regulatory submissions.

Key activities:

- Actively participate in strategic discussions with cross functional team members.

- Plan regulatory activities for assigned projects.

- Serve as the primary person responsible for implementing regulatory activities for assigned projects including:

• Pre submission activities including consultations with health authorities

• Submission of applications/notifications to health authorities

• Responding to inquiries from health authorities

• Provide post approval support including reimbursement notifications and copy review.

- Life cycle management (e.g. maintenance of licenses change assessments).

- QMS compliance (including training and audit support) and other cross functional collaboration as required.

Required qualifications:

- More than 5 years of experience in regulatory affairs for medical devices.

- Comprehensive understanding of the Japanese PMD Act and associated regulations.

- Demonstrated leadership and communication skills and English proficiency sufficient to lead internal regulatory discussions via conference calls for assigned projects.

- Proficient with standard PC applications (Microsoft Excel Word PowerPoint PDF etc.).

Preferred experiences and skills:

- Experience with registration of cardiovascular products.

Experience in regulatory submissions using local/global clinical trial or evidence.

If you are Japan employee please read Internal Application Guideline in Ask GS. Especially if you are less than 18 months in your current role you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japans employee you are not able to apply for multiple positions at once.
Once you move to 1st interview stage please make sure to inform to your current manager.
For Employee Referral Program (ERP) please read and understand the details of Employee Referral Program in Ask GS and make a compliant referral.

応募の際はAskGS内の社内公募ガイドラインをご一読いただき応募ください１８か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください複数同時応募不可になります
在籍期間に関わらず書類選考を通して１次面接に進んだ場合は社内公募に応募し選考に進むことを上司に報告してください
社内紹介を行う場合はASK GS上のEmployee Referral Programの詳細を理解した上でコンプライアンスを守って紹介したものとみなします

Required Skills:

Preferred Skills: