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Global RA

年収:800万 ~ 2000万

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部署・役職名 Global RA
職種
業種
勤務地
仕事内容 JOB TITLE: GLOBAL REGULATORY OPERATION LEADER
DIVISION: REGULATION, QUALITY AND GOVERNMENT AFFAIRS DEPT
GLOBAL HEAD QUARTER
REPORTING TO: VP, GLOBAL HEAD REGULATION, QUALITY AND GOVERNMENT AFFAIRS DEPT

MAIN PURPOSE OF JOB
As the Regulatory Operation Leader at Headquarters, by maintaining cooperation with internal and external stakeholders, this person should confirm and secure that the operations to register and launch products to each country are being carried out in compliance with regulations and various standards.

MAIN JOB DUTIES / RESPONSIBILITIES
1) Obtain and understand the regulations and various standards related to the launch of products in each country, collaboration with relevant divisions, consideration of timeline, and confirm business confirmation by audits. This task includes the establishment of system to clarify the regulations and standards needed to be complied and monitored to reach the compliance within each division.
2) Provide proper guidance according to the conformity situation to the divisions, and lead improvements and reforms for conformity if necessary. It also includes the proposal and establishment of a market launch / regulatory approval plan management system for this purpose.
3) In order to carry out the above, this position will collaborate with other head office quality regulatory group (QRG) members and divisions to optimize related organizations and their operations as well as provide education for the development of highly capable human resources.
4) Becoming a representative of the Global database that monitors regulatory information, and management of the system, as well as proposals and developing additional systems as needed.
5) Participate as one of auditees in audits conducted by the government and third-party certification bodies and take necessary pre- and post-action measures.
6) If necessary, participate in industry activities and carry out necessary negotiations with Government agencies in collaboration with business divisions.
7) Create internal and external reports required by Global Headquarters.

REQUIREMENTS
1) University bachelor's degree in physics and chemistry or similar knowledge
NECESSARY KNOWLEDGE AND EXPERIENCES
(1) Have in-depth knowledge of Japanese Pharmaceutical and Medical Device Affairs’ Law, FDA, EU-MDD/MDR, NMPA-related product launch regulations, and have at least work experience with one of these (management is also possible).
(2) Have knowledge of product launch regulations in ANVISA/TGA/CMDCAS.
(3) Have knowledge of the situation of AMDD.
(4) Have knowledge about QMS/QSR/GVP and experience of auditing / auditing (ISO13485, ISO14971, 21 CFR Part 803/820, etc., IEC related, QMS/GMP regulations and safety management regulations of Japan and China, EU -MDD/MDR, AMDD, etc.).
(5) Basic understanding of multiple ethical guidelines (including the Declaration of Helsinki) related to clinical research, clinical research methods, ISO14155, 21CFR Part 50/807/815, GCP regulations in Japan and China, any of ES/ER guidelines, etc.
(6) Have basic knowledge of sterilization and biochemical safety tests, ISO 10993, 11737, 11607, etc.
(7) Have basic knowledge of international regulations on chemical substances.

SKILLS AND COMPITENCY
-Good communication skill, with respecting others 
-Good people and project management experiences and skill
-Logical thinking 
-Business oriented but compliance and quality as primary focus 
-English: Business level (there will be occasions that this person leads meetings with several regional leaders by alone)

PREFERENCES
-Having good relations with key physicians
-Having Pipeline to related Government body, notified body, industry associations
-Good to manage statistics

応募資格

【必須(MUST)】

REQUIREMENTS
1) University bachelor's degree in physics and chemistry or similar knowledge
NECESSARY KNOWLEDGE AND EXPERIENCES
(1) Have in-depth knowledge of Japanese Pharmaceutical and Medical Device Affairs’ Law, FDA, EU-MDD/MDR, NMPA-related product launch regulations, and have at least work experience with one of these (management is also possible).
(2) Have knowledge of product launch regulations in ANVISA/TGA/CMDCAS.
(3) Have knowledge of the situation of AMDD.
(4) Have knowledge about QMS/QSR/GVP and experience of auditing / auditing (ISO13485, ISO14971, 21 CFR Part 803/820, etc., IEC related, QMS/GMP regulations and safety management regulations of Japan and China, EU -MDD/MDR, AMDD, etc.).
(5) Basic understanding of multiple ethical guidelines (including the Declaration of Helsinki) related to clinical research, clinical research methods, ISO14155, 21CFR Part 50/807/815, GCP regulations in Japan and China, any of ES/ER guidelines, etc.
(6) Have basic knowledge of sterilization and biochemical safety tests, ISO 10993, 11737, 11607, etc.
(7) Have basic knowledge of international regulations on chemical substances.

SKILLS AND COMPITENCY
-Good communication skill, with respecting others 
-Good people and project management experiences and skill
-Logical thinking 
-Business oriented but compliance and quality as primary focus 
-English: Business level (there will be occasions that this person leads meetings with several regional leaders by alone)




【歓迎(WANT)】

PREFERENCES
-Having good relations with key physicians
-Having Pipeline to related Government body, notified body, industry associations
-Good to manage statistics

更新日 2021/05/10
求人番号 1744318

採用企業情報

  • Hoya Corporation
  • 会社規模501-5000人
  • 会社概要

    ABOUT US
    We are a Global Med-Tech Company Head Quartered in Tokyo Japan.
    Established in 1941, we are famous for our medical endoscopes, optical lenses, Orthopedic implants, and surgical instruments, with an ever developing pipeline for innovative technology.
    Our mission is to seek innovation for a better future.
    We are pleased to employ a multinational work force of 37,000 people world wide across our 150 offices and subsidiaries, committed to bringing patients innovative high-tech medical products.

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