Job ID : 1069898 Date Updated : October 14th, 2020
Genetic Diagnosis Company

Safety (PMS) Specialist

Hiring Company 非公開
Location Tokyo - 23 Wards
Job Type Permanent Full-time
Salary 7.5 million yen ~ 9 million yen

Job Description

Company Profile:

Our client is a global leader in products and services for innovative technology.

Responsibilities:

  • Manage and maintain the QMS for licensing of medical devices by performing safety data management and cooperating with quality assurance activities.
  • Complaint handling (Review collected quality and safety information, including recalls, from domestic or overseas and ensure local reporting requirements are met by processing corresponding notifications to the authority in Japan)
  • Involved in Registration/Application process in Japan of various classes of Medical Devices. Prepare registration applications and process filings with various local agencies in Japan (MHLW, PMDA, Notified Body and the like).
  • Be able to manage interactions with local authorities as well as to support all applicable audit proceedings.
  • Work with overseas RA/QA team to obtain the necessary documentation to support registrations in Japan.
  • Provide support to other regulatory compliance activities as assigned by the manager.

General Requirements

Minimum Experience Level Over 3 years
Career Level Mid Career
Minimum English Level Daily Conversation
Minimum Japanese Level Native
Minimum Education Level Bachelor's Degree
Visa Status Permission to work in Japan required

Required Skills

  • 3+ years' experience as a safety manager in a medical device industry, or 3+ years' experience in securing safety management work or equivalent job duties is required (including; work for post-marketing surveillance practice in pharmaceuticals or medical devices adverse event reporting ).
  • Basic computer skills (Word, Excel, Power Point) are necessary
  • Native level in Japanese and fluent in English (Writing, reading, spoken)
  • Communication skill and cooperative personality

Preferred Background:

  • Minimum B.S. degree in biological science, chemistry, medical, engineering, or life science related area; Master of Science Degree preferred.
  • Knowledge of QMS ISO 9001/13485 as well as Japan's QMS requirements for Medical Devices
  • Knowledge of Japan's Regulations for Medical Devices (all product classes) including STED preparation.

Job Location

  • Tokyo - 23 Wards

Work conditions

Job Type Permanent Full-time
Salary 7.5 million yen ~ 9 million yen
Work Hours 会社規定に準ずる

Hiring Company Information

Company Type International Company
Recruiter Company Information

PERSOL CAREER CO., LTD.(Bilingual Recruitment Solutions)

Safety (PMS) Specialist - 1069898

Company Description

バイリンガル・リクルートメント・ソリューションズ(BRS)は、パーソルキャリア株式会社のバイリンガル /マルチリンガル専門部署です。職種別のコンサルタントが、専門性と人脈を活かした丁寧なコンサルティングを通して、語学力を活かしたい転職希望者様と即戦力を求める日系/外資系企業をおつなぎします。

【BRS東京オフィス】
〒1020094
東京都 千代田区 紀尾井町4-1
ニューオータニ ガーデンコート18F

【BRS大阪オフィス】
〒5300011
大阪府 大阪市北区 大深町3-1
グランフロント大阪タワーB 17F

Bilingual Recruitment Solutions (BRS) is a division of PERSOL CAREER CO., LTD. that focuses on connecting multilingual professionals with businesses across all industries in Japan. Those looking for a bilingual/multilingual career will find our position in the market to be unique; our consultants are able to provide tailored career counseling based on job specializations, while at the same time leveraging the extensive resources of PERSOL CAREER.

BRS Tokyo Office
18F New Otani Garden Court
4-1 Kioi-cho, Chiyoda-ku
Tokyo, Japan, 1020094

BRS Osaka Office
17F, Grand Front Osaka Tower B
3-1 Ofukacho, Osaka-shi Kita-ku
Osaka, Japan, 5300011