Pharmaceutical consulting for medical equipment consulting business

Application deadline date has been passed for this Job.
Full-Time Employee
  • Post Date: 2019-08-23
  • Career Level Others
  • Offerd Salary ¥4 - ¥6 Million
  • Experience Less than 1 Year
  • Number of employee up to 5 people
  • Gender Required Both
  • INDUSTRY Other
  • Qualification Associate Degree
  • Working Hour 9:30 to 18:30
  • Trial Period 3 months
  • Department Assign Research & Consulting
Job Description

Consultants related to business strategies for clients in the medical device field 

(specifically) 

◼︎ Supports commercialization of leading manufacturers and venture companies in the cutting-edge industrial science field in Japan and overseas through consulting and document creation support and new entrants survey of laws and regulations, an overseas strategy and sales strategy of consulting and strategy development support one product of the requirements and legal regulations, certification and licensing application, design, development, production, Sales documentation, etc. Designation and manufacturing requirements (regulations and standards) identification, technical document creation and management, quality management system ( QMMS ) construction and operation consulting and documentation support. 

◼︎ Investigating methodologies for commercialization support and document creation, and accumulation of know-how 

◼︎ Other lectures and lectures related to the above work (in seminars, etc.) 

[Main examples] 

・Consultation on the development of wearable robots (safety regulation requirements) , Insurance listing, promotion code, development professional for Japan and Europe Modeling), 

verbal assessments regarding global compliance (pharmaceutical regulations, promotional codes, information security of personal health records ) for wearable biological information sensor application products, risk assessment of robotic devices for medical treatment, welfare, and nursing Support for usability testing and creation of related technical documents 

・Quality management system (QMS) construction support and documentation for ICT-related equipment manufacturers 

・Consultation for full-scale entry into the medical equipment industry by material processing manufacturers 

・Europe and America and Asia Survey on laws and regulations on communication equipment and medical equipment


Hiring requirements

・Those who have experience in any of the following three points 

(1) European medical device CE marking documents can be created and consulted. 

(2) 1S0 13485: 2016 and domestic manufacturing and sales documents can be made and consulted. 

(3) Documents for manufacturing / sales approval / certification for domestic medical devices can be prepared and consulted. 

・TOEIC 850 or more equivalent English reading ability (because the survey target is often in English. There is no use other than reading) 

[Welcome requirements] 

・European medical standards experienced person welcome 

・Internal and external Emphasize the ability to build good relationships


Wage system

Full monthly salary


Break time

60 minutes

overtime work

There is a monthly average of about 30 hours


Discretionary labor system & fixed overtime system

– Fixed overtime 

– pay basic salary: 346,000 yen to 421,000 yen 

– Fixed overtime pay: 120,000 yen to 146,000 yen 

– Fixed overtime hours: 

– Additional wages for overtime work exceeding 45 hours fixed overtime hours: Yes


Treatment conditions / sales bonus

[Annual income] 

・People who are ready to work in the mid-30’s or higher may be offered in positions that are not eligible for overtime pay. 

・Concerning annual income, consultation is required considering experience / previous job. 

・Includes a flat housing allowance of ¥ 15,000 

[Bonus] 

・Bonus twice a year (Amount paid in the first year: 200 to 300,000 yen) 

[Salary revision] 

・Once a year 

[Several benefits and treatment] 

・Commutation allowance (separate payment, upper limit of 10) 10,000 yen / month) 

・House allowance, fixed overtime allowance, excess overtime allowance, family allowance (for dependents)


Welfare

Health insurance, employment insurance, occupational accident insurance, welfare pension


Selection process

– Primary interview (assigned department + HR) 

– Written exam (home)  

– Review about written exam + Secondary interview (Head of the headquarters + officer) 

* Written exam is a test to check survey methods, report creation methods, knowledge, etc. 

* The review of the written examination assumes a question-and-answer session about how the investigation and report were written in the written examination (held about 30 minutes on the same day as the second interview) of planned) 

* aptitude test the final interview with the implementation schedule at the same time


Holiday

・Annual holiday days 

・128 days (FY2019 results) 

・Full 

week off days (Saturdays, Sundays, and holidays) 

・Childcare leave: System available 

・Achievements (100% return to work) 

・New year holidays, paid leave, establishment day leave (August 1) Gyeonghui vacation

・The working conditions, etc. specified in this job of