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Updated 2025-02-19
Activated 2025-02-19

Biocompatibility Specialist

NEW
Company Name

HCL JAPAN LTD./株式会社エイチシーエル・ジャパン

Job Type
HCL JAPAN LTD./株式会社エイチシーエル・ジャパン
Medical/Pharmaceutical/Bio/Fabric/Food - Research
Medical/Pharmaceutical/Bio/Fabric/Food - Valuation/Testing
Medical/Pharmaceutical/Bio/Fabric/Food - Production R & D
Industry Medical devices
Location Asia Japan Tokyo Others

Job Description Currently we're hiring mid-career Biocompatibility Specialist to join our project in Tokyo, to join our existing team to provide technical deliverables to client.

Do you want to leverage your technical knowledge / experience and join our subject matter expert team?

This is a great opportunity to join HCLTech family to advance your career in a dynamic service delivery and business model!

We welcome candidates who are already working in Japan with valid work permit, able to work full-time.

Responsibilities:

 Preparation of study design for materials characterization and biocompatibility testing as per ISO-10993 standards or as per required guidelines.
 Conducting gap assessment, prepare rationale or justification for exemption of materials or biocompatibility testing.
 Test lab coordination, supplier audit, report preparation and on-boarding supplier.
 Sample assessment, worst-case sample selection, sample procurement, and shipment to test lab.
 Test item data sheet preparation, study protocol review, stakeholders connect to get the approval for execution of studies.
 Study monitoring, raw data verification, data analysis and interpretation, report review and finalization.
 Summary report preparation and routing to customer PLM portal.
 Materials assessment in compliance with REACH/RoHS/Prop65, preparation of hazardous assessment report as per various regulations including EU-MDR Annex I GSPR.
 Preparation of biological safety evaluation plan and report for various classes of medical devices (Class I-III) per EU-MDR, ISO 10993-1 and FDA guidance on ISO 10993-1.
 Analysis and interpretation of extractable and leachable testing data and interpretation.
Company Info About HCL:
Founded in 1976 as one of India's original IT garage start-ups, HCL is a pioneer of 
modern computing with many firsts to its credit, including the introduction of the 8-bit microprocessor-based computer in 1978 well before its global peers. Today, the HCL enterprise has a presence across varied sectors that include technology, healthcare and talent management solutions and comprises three companies - HCL Technologies, HCL Infosystems, and HCL Healthcare. The enterprise generates annual revenues of over US $ 13.8 billion as of 12 months ending December 2024 with more than 220,755+ employees from 140 nationalities operating across 60 countries, including over 500 points of presence in India.

About HCL in Japan
For nearly two decades, HCL has helped over 40 Japanese companies through account outsourcing, modernization of legacy systems, optimizing costs, improving business processes, and transforming their businesses. As one of the established software companies in Japan, HCL’s primary objective has been to enable the global growth strategy for brands in the region. Our product localization services help software development companies in Japan tailor their products to the requirements of foreign markets. Our value engineering and re-engineering services help redesign products to cater to emerging markets

For further information, visit www.hcl.com

Online interview by default, if required minimal face to face interview.

【Measures against passive smoking】
Designated smoking area mostly outside the office building
Working Hours 8 hours per day with 1 hour break (by default, it may change slightly depends on client)
Job
Requirements		  Minimum 5 year’s experience in materials characterization, materials testing, biocompatibility testing.
 Knowledge in materials suitable to medical device.
 Material assessment, materials characterization, hazardous identification, materials testing, and compatibility assessment.
 Experienced on ROHS, REACH and CMR/ED assessment for USA, Europe, China and other regulations.
 Experience on materials testing, medical device biocompatibility testing and biological safety evaluation, and risk assessment.
 Knowledge on various analytical techniques - Spectra/FTIR/ICP-MS/GC-MS/LC-MS, extractable/leachability testing.
 Adaptive and flexible interpersonal skills, collaborative nature, and commitment to innovation are required.
 Exceptional communication and technical documentation skills are required.
 Excellent oral communication & report, business correspondence & procedure-writing skills.
 Change agent with energy, passion, and enthusiasm to drive change.
 Ability to multitask and handle tasks with competing priorities effectively.
 Self-initiator, results driven and action & detail oriented.
 Knowledge on Medical device regulations and practice is a plus.
English Level Business Conversation Level (TOEIC 735-860)
Japanese Level Business Level(JLPT Level 2 or N2)
Salary JPY - Japanese Yen JPY 4500K - JPY 8000K   
Other Salary
Description		 Social Insurance
Paid holiday
Education Training
No additional commutation allowance (inclusive salary)
Overtime will be additionally paid

* HCL Japan offers salary as the annual salary package (inclusive a few percentages of variables / bonus) --we'll confirm and share the breakdown at the time of offer
Holidays Five-Day Workweek
Paid Holidays
Congratulatory or Condolence Leave
Child-care Leave
Job Contract
Period		 Full-time/permanent
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