医療機器薬事リーダー / Medical Device Regulatory Leader

FDA対応等，グローバル展開を目的とした各国海外申請を含む）

PHCソリューションの開発に薬事機能として関わることで、医療機器と医薬品の双方の価値最大化に貢献できる。

Background to appointment :

Due to the increase in medical device development themes (including programs / digital tools), it is necessary to ensure persons with experience of pharmaceutical affairs.

You will :

Promotion and implementation of medical device regulatory strategy from planning to regulatory approval (Including overseas applications in each country for the purpose of global expansion such as engagement with US FDA)

Quality control of medical devices in compliance with laws and regulations of each country in cooperation with our company Quality Assurance Department

Position Features :

By being involved in the development of new PHC solutions as a regulatory function, we can contribute to maximizing the value of both medical devices and drugs. 応募資格／Qualifications 求める経験：

3年以上）

FDAを含む）への薬事申請，承認取得の経験

TOEICを含む）：

TOEIC 700点以上

Required Qualifications :

Experience as a regulatory leader in medical device regulatory applications (at least 3 years)

Experience in applying to and obtaining approval from overseas regulatory authorities (including the US FDA)

Experience with quality control of medical devices preferred

Team management experience preferred

Preferred Knowledge and Skills :

Knowledge of domestic and overseas medical device regulations

Able to converse and communicate at a business level in both Japanese and English

Who You Are :

Draw up what the team wants to achieve, draw up strategic action plans, and concentrate on creating results.

Even when faced with difficult issues or unknown phases for which the correct answers cannot be found, think from a bird's eye view, rouse ourselves to find solutions, and continue to take on challenges with colleagues without giving up.

Create value with people with diverse values such as domestic and overseas stakeholders (Partner companies such as manufacturing sites, regulatory authorities, etc.) and in-house related departments without bothering with cross-cultural communication.

Desired Qualification：

TOEIC 700+ points 待遇／Salary & Benefits 当社規定により優遇いたします。

To be decided in accordance with our criteria.

Flextime system

The notification of working conditions will be made in an electronic file.

If you apply, please understand this point.