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Regulatory Affairs Expert / Quality and Regulatory Management_Life Science at The businesses of Merck KGaA, Darmstadt, Germany
Tokyo, Tokyo, Japan - Full Time
Skills Needed
Regulatory Affairs, Quality Management, Communication, Gmp Compliance, Dmf Management, Medical Device Approval, Pharmaceutical Regulations, Import Verification, Global Regulatory Trends, Collaboration, English Proficiency, Pharmacy License, Quality Assurance, Cmc Experience, Regulatory Consultation, Manufacturing Inspection
Specialization
Candidates must possess a pharmacy license and be comfortable with daily communication in English. Experience in regulatory submissions, quality assurance, or CMC in the healthcare industry is preferred.
Experience Required
Minimum 2 year(s)
Strategy Director (Tokyo) at AKQA
Tokyo, , Japan - Full Time
Skills Needed
Strategic Leadership, Data Analysis, Creative Process, Qualitative Research, Quantitative Research, Business Strategy, Brand Planning, Communication Skills, Team Management, Customer Service, Innovation, Entrepreneurial Mindset, Problem Solving, Mentoring, Collaboration, Flexibility, Cultural Awareness
Specialization
Candidates must have 12-15 years of experience in a strategic discipline, with a strong background in digital, communications, or consulting. They should possess skills in product strategy, brand planning, and the ability to analyze and communicate insights effectively.
Experience Required
Minimum 10 year(s)
【置き配メイン】AIルート配送|1日22,120円（差し引き一切ナシ）週払いあり at 合同会社DEXIS
, , Japan - Full Time
Skills Needed
Driving, Delivery, Customer Service, Time Management, Navigation, Communication
Specialization
Candidates must possess a standard driver's license (AT allowed) and have a willingness to learn, as no prior experience is required. The position is open to individuals aged 18 to 60, with no educational qualifications specified.
Customer Success Representative at Veeam Software
Tokyo, , Japan - Full Time
Skills Needed
Customer Success, Sales, Account Management, Coaching, Analytical Skills, Communication Skills, Organizational Skills, Salesforce.Com Proficiency, Data Analysis, Negotiation, Technical Support, Customer Engagement, Forecasting, Mentorship, Problem Solving, Time Management
Specialization
Candidates should have a minimum of 3 years of relevant experience in sales or customer success roles and possess strong analytical and communication skills. A proven track record of meeting quotas and the ability to train and mentor new hires are also essential.
Experience Required
Minimum 2 year(s)
Segment Leader at Valeo
Tokyo, , Japan - Full Time
Skills Needed
Supplier Management, Negotiation, Risk Mitigation, Performance Monitoring, Budget Management, Project Management, Data Analysis, Sourcing Strategy, Supplier Relationship Management, Cost Reduction, Market Analysis, Ethics Compliance, Collaboration, Continuous Improvement, Decision Making, Stakeholder Engagement
Specialization
Candidates should have experience in purchasing and supplier management, with a focus on negotiation and performance improvement. A strong understanding of market dynamics and the ability to analyze key performance indicators is essential.
Experience Required
Minimum 5 year(s)
シニアリクルーター | Senior Recruiter, People and Performance at Colliers International EMEA
Tokyo, Tokyo, Japan - Full Time
Skills Needed
Recruitment, Talent Sourcing, Stakeholder Management, Candidate Selection, Candidate Experience, Recruitment Branding, Data Management, Compliance, Team Support, Communication, Negotiation, Organizational Skills, Attention To Detail
Specialization
Candidates should have over 7 years of experience in recruitment, ideally with both agency and in-house experience, and experience in the real estate industry is preferred. Proficiency in Japanese at a native level and business-level English is required, along with strong communication and relationship-building skills.
Experience Required
Minimum 5 year(s)
Partner Acquisition Sales at American Express Company South Africa
Minato, , Japan - Full Time
Skills Needed
Corporate Sales, Solution Selling, Partner Management, Communication Skills, Negotiation Skills, Problem Solving, Relationship Building, Business Development, Market Research, Strategic Planning, Team Collaboration, Customer Needs Assessment, Insightful Analysis, Goal Orientation, Flexibility, Creativity
Specialization
Candidates should possess strong goal orientation and proactive communication skills. They must be able to identify client needs and propose high-value solutions to drive business expansion.
Experience Required
Minimum 2 year(s)
【オープニング】Amazonのオフィシャル配送サービスパートナー｜未経験でも「初月から」44万円以上の報酬◎【AT限定可】 at 株式会社アイビスオーク
Nishinomiya, , Japan - Full Time
Skills Needed
Driving, Delivery, Customer Service, Time Management, Safety Awareness, Route Planning, Communication, Problem Solving, Teamwork, Adaptability
Specialization
Candidates must possess a standard driver's license (AT allowed) and have a willingness to learn. No specific educational background or prior experience is required.
MA/MBL11-APAC, Data Analytics Specialist [Intern] at Bosch Group
, , Japan - Full Time
Skills Needed
Data Analytics, Ai Application, Data Management, Data Governance, Python, R, Sql, Machine Learning, Generative Ai, Git, Workflow Automation, Statistics, Engineering, Computer Science, Analytical Mindset, Data Integrity
Specialization
Candidates should be students in Analytics, Statistics, Computer Science, Engineering, or other quantitative fields with a strong foundation in data analytics. Fluency in English is required, with intermediate Japanese or Chinese preferred.
R&D Chemist – Sealants at Sika AG
Hiratsuka, , Japan - Full Time
Skills Needed
Polymer Chemistry, Emulsions, Rheology, Formulating, Waterproofing Membranes, Testing Methods, Manufacturing Processes, Analytical Instruments, Problem Solving, Attention To Detail, Communication Skills, Teamwork, Time Management
Specialization
Candidates must have a Bachelor’s or Master’s degree in Chemistry or a related field, along with 3-5 years of experience in R&D for waterproofing coatings or sealants. Proficiency in Japanese is required, with intermediate English skills preferred.
Experience Required
Minimum 2 year(s)
Production Director at AKQA
Tokyo, , Japan - Full Time
Skills Needed
Production Leadership, Client Management, Budgeting, Risk Management, Creative Collaboration, Vendor Management, Team Leadership, Communication Skills, Film Production, Content Production, Integrated Campaigns, Stakeholder Management, Operational Excellence, Proposal Development, Mentoring, Creative Integrity
Specialization
Candidates should have 8+ years of experience in production leadership roles and a proven track record in delivering large-scale brand and communication projects. Strong experience in film production, content production, and integrated campaigns is essential, along with excellent client-facing skills.
Experience Required
Minimum 10 year(s)
Partnership Manager, APAC at Classiq
Tokyo, , Japan - Full Time
Skills Needed
Partnership Management, Channel Management, Business Development, Strategic Partnerships, Market Penetration, Ecosystem Development, Cross Functional Collaboration, Performance Management, Relationship Building, Negotiation, Conflict Resolution, Technology Landscape Knowledge, Revenue Generation, Sales Alignment, Training And Enablement, Kpi Tracking
Specialization
Candidates should have 7+ years of experience in channel management or strategic partnerships, preferably in the APAC region. A deep understanding of the technology landscape and fluency in Japanese and English are also required.
Experience Required
Minimum 5 year(s)
Quantum Solutions Architect, APAC at Classiq
Tokyo, , Japan - Full Time
Skills Needed
Quantum Computing, Sales, Technical Discovery, Customer Engagement, Quantum Algorithms, Communication Skills, Quantum Software Engineering, Problem Solving, Technical Demos, Cross Functional Collaboration, Machine Learning, Ai
Specialization
Candidates should have 3+ years of experience in a customer-facing technical role and a degree in Computer Science or a related field, with a preference for those with a Ph.D. Excellent communication skills and experience in quantum information or quantum algorithms are also required.
Experience Required
Minimum 5 year(s)
Market HR Partner at NielsenIQ
, , Japan - Full Time
Skills Needed
Human Resources, Talent Management, Employee Relations, Compensation, Compliance, Hr Technology, Data Analysis, Change Management, Diversity, Equity, Inclusion, Communication, Financial Acumen, Organizational Effectiveness, Performance Management, Coaching
Specialization
A bachelor's degree in human resources or a related field is required, along with at least 4 years of relevant HR experience. Strong communication skills in both English and Japanese, as well as knowledge of local laws and HR practices, are essential.
Experience Required
Minimum 5 year(s)
ファイナンス トランザクショナル スペシャリスト at Eurofins
Chiyoda, Nishikanda, Japan - Full Time
Skills Needed
Accounting, Ap, Ar, Expense Reimbursement, Taxation, Project Participation, Team Collaboration, Microsoft Excel, Microsoft Word, Microsoft Powerpoint, Japanese Language, English Language, Interpersonal Skills, Problem Solving, Continuous Improvement, Flexibility
Specialization
Candidates should have 3-5 years of practical experience and possess both independent work capabilities and teamwork skills. Proficiency in Japanese (native or JLPT N1) and English (reading and writing) is required.
Experience Required
Minimum 2 year(s)
Functional Architect at GUIDEWIRE SOFTWARE INC
Tokyo, , Japan - Full Time
Skills Needed
Japanese Language, English Language, Software Development, Consulting, Communication Skills, Leadership, Organizational Skills, Customer Service, Agile Development, Web Application Development, Object Oriented Programming, Cloud Platforms, Data Modeling, Ui/Ux Design, Guidewire Products, Insurance Knowledge
Specialization
Candidates must have over 7 years of experience in software development and consulting, with strong communication and leadership skills. Proficiency in Japanese and English is required, along with technical expertise in web application development and cloud platforms.
Experience Required
Minimum 5 year(s)
NVIDIA platform engineer for Automotive Application / 自動車アプリケーション向けNVIDIAプラ at Quest Global
Kawasaki, , Japan - Full Time
Skills Needed
Nvidia Experience, Orin, Drive Os, Sipl, Qnx, Automotive Industry Experience
Specialization
Candidates must have experience with NVIDIA software, ORIN/Drive OS, SIPL, QNX, and in the automotive industry. Japanese language proficiency at JLPT N2 level or above is required, while English is not mandatory.
Experience Required
Minimum 2 year(s)
Responsibilities Profile at lectrasa
Tokyo, , Japan - Full Time
Skills Needed
Global Account Management, Sales Strategy, Customer Relationship Management, Consultative Selling, Negotiation, Project Management, Software Sales, Saas Business Model, Digital Solutions, Emerging Technologies, Cross Cultural Communication, Team Collaboration, Customer Satisfaction, Risk Management, Industry Trends, Presentation Skills
Specialization
Candidates must have a minimum of 5 years of experience managing large Japanese automotive accounts and a solid background in software sales. Preferred qualifications include experience with digital solutions and a university degree in business or engineering.
Experience Required
Minimum 10 year(s)
Order Management II at Applied Materials
Tokyo, , Japan - Full Time
Skills Needed
Order Management, Customer Service, Sales Orders, Erp Systems, Problem Solving, Communication, Technical Knowledge, Relationship Management
Specialization
Candidates should demonstrate expanded conceptual knowledge in their discipline and possess problem-solving skills. The role does not require supervisory responsibilities but involves providing informal guidance to new team members.
サージカル営業職（大阪） at Alcon
Osaka, , Japan - Full Time
Skills Needed
Sales Experience, Medical Industry Experience, Healthcare Experience, Customer Relationship Management, Surgical Equipment Knowledge, Communication Skills, Problem Solving, Time Management
Specialization
Candidates must have at least three years of sales experience and three years of experience in the medical field, such as nursing or medical engineering. Experience in the healthcare industry is preferred.
Experience Required
Minimum 5 year(s)
Regulatory Affairs Expert / Quality and Regulatory Management_Life Science at The businesses of Merck KGaA, Darmstadt, Germany
Tokyo, Tokyo, Japan -
Full Time

Start Date

Immediate

Expiry Date

24 Mar, 26

Salary

0.0

Posted On

24 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Quality Management, Communication, GMP Compliance, DMF Management, Medical Device Approval, Pharmaceutical Regulations, Import Verification, Global Regulatory Trends, Collaboration, English Proficiency, Pharmacy License, Quality Assurance, CMC Experience, Regulatory Consultation, Manufacturing Inspection

Industry

Pharmaceutical Manufacturing

Description
ポジション： Life Science Regulatory Management : Regulatory Specialist レポートライン: Regulatory senior Manager日本人 勤務先： 東京勤務（週２日 在宅ワーク可） 職務内容： 以下の業務をRegulatory Expertと共に業務を行います。 ・DMF新規、変更及び維持管理（原薬及び添加剤等）と製販への連絡 ・外国製造業者認定の代理人としての業務 ・体外診断用医薬品/医療機器 承認申請維持管理 ・申請書内容と製造実態との定期的点検 ・PMDA相談 ・GMP適合性調査対応 ・輸入確認（薬監証明） ・法改正動向確認及びグローバル薬事への展開 応募要件： ・薬剤師免許取得 ・日常的な英文メールのやりとりに拒否反応が無いこと。 ・他部署と積極的にコミュニケーションが取れること。 ・医療業界で、薬事申請、品質保証又はCMC経験がある方は歓迎します。
Responsibilities
The role involves managing DMF submissions and maintenance, acting as a representative for foreign manufacturers, and overseeing approval applications for in vitro diagnostic drugs and medical devices. Additionally, it includes regular inspections of application contents against manufacturing realities and responding to GMP compliance investigations.
Regulatory Affairs Expert / Quality and Regulatory Management_Life Science at The businesses of Merck KGaA, Darmstadt, Germany
Tokyo, Tokyo, Japan - Full Time
Skills Needed
Regulatory Affairs, Quality Management, Communication, Gmp Compliance, Dmf Management, Medical Device Approval, Pharmaceutical Regulations, Import Verification, Global Regulatory Trends, Collaboration, English Proficiency, Pharmacy License, Quality Assurance, Cmc Experience, Regulatory Consultation, Manufacturing Inspection
Specialization
Candidates must possess a pharmacy license and be comfortable with daily communication in English. Experience in regulatory submissions, quality assurance, or CMC in the healthcare industry is preferred.
Experience Required
Minimum 2 year(s)
Strategy Director (Tokyo) at AKQA
Tokyo, , Japan - Full Time
Skills Needed
Strategic Leadership, Data Analysis, Creative Process, Qualitative Research, Quantitative Research, Business Strategy, Brand Planning, Communication Skills, Team Management, Customer Service, Innovation, Entrepreneurial Mindset, Problem Solving, Mentoring, Collaboration, Flexibility, Cultural Awareness
Specialization
Candidates must have 12-15 years of experience in a strategic discipline, with a strong background in digital, communications, or consulting. They should possess skills in product strategy, brand planning, and the ability to analyze and communicate insights effectively.
Experience Required
Minimum 10 year(s)
【置き配メイン】AIルート配送|1日22,120円（差し引き一切ナシ）週払いあり at 合同会社DEXIS
, , Japan - Full Time
Skills Needed
Driving, Delivery, Customer Service, Time Management, Navigation, Communication
Specialization
Candidates must possess a standard driver's license (AT allowed) and have a willingness to learn, as no prior experience is required. The position is open to individuals aged 18 to 60, with no educational qualifications specified.
Customer Success Representative at Veeam Software
Tokyo, , Japan - Full Time
Skills Needed
Customer Success, Sales, Account Management, Coaching, Analytical Skills, Communication Skills, Organizational Skills, Salesforce.Com Proficiency, Data Analysis, Negotiation, Technical Support, Customer Engagement, Forecasting, Mentorship, Problem Solving, Time Management
Specialization
Candidates should have a minimum of 3 years of relevant experience in sales or customer success roles and possess strong analytical and communication skills. A proven track record of meeting quotas and the ability to train and mentor new hires are also essential.
Experience Required
Minimum 2 year(s)
Segment Leader at Valeo
Tokyo, , Japan - Full Time
Skills Needed
Supplier Management, Negotiation, Risk Mitigation, Performance Monitoring, Budget Management, Project Management, Data Analysis, Sourcing Strategy, Supplier Relationship Management, Cost Reduction, Market Analysis, Ethics Compliance, Collaboration, Continuous Improvement, Decision Making, Stakeholder Engagement
Specialization
Candidates should have experience in purchasing and supplier management, with a focus on negotiation and performance improvement. A strong understanding of market dynamics and the ability to analyze key performance indicators is essential.
Experience Required
Minimum 5 year(s)
シニアリクルーター | Senior Recruiter, People and Performance at Colliers International EMEA
Tokyo, Tokyo, Japan - Full Time
Skills Needed
Recruitment, Talent Sourcing, Stakeholder Management, Candidate Selection, Candidate Experience, Recruitment Branding, Data Management, Compliance, Team Support, Communication, Negotiation, Organizational Skills, Attention To Detail
Specialization
Candidates should have over 7 years of experience in recruitment, ideally with both agency and in-house experience, and experience in the real estate industry is preferred. Proficiency in Japanese at a native level and business-level English is required, along with strong communication and relationship-building skills.
Experience Required
Minimum 5 year(s)
Partner Acquisition Sales at American Express Company South Africa
Minato, , Japan - Full Time
Skills Needed
Corporate Sales, Solution Selling, Partner Management, Communication Skills, Negotiation Skills, Problem Solving, Relationship Building, Business Development, Market Research, Strategic Planning, Team Collaboration, Customer Needs Assessment, Insightful Analysis, Goal Orientation, Flexibility, Creativity
Specialization
Candidates should possess strong goal orientation and proactive communication skills. They must be able to identify client needs and propose high-value solutions to drive business expansion.
Experience Required
Minimum 2 year(s)
【オープニング】Amazonのオフィシャル配送サービスパートナー｜未経験でも「初月から」44万円以上の報酬◎【AT限定可】 at 株式会社アイビスオーク
Nishinomiya, , Japan - Full Time
Skills Needed
Driving, Delivery, Customer Service, Time Management, Safety Awareness, Route Planning, Communication, Problem Solving, Teamwork, Adaptability
Specialization
Candidates must possess a standard driver's license (AT allowed) and have a willingness to learn. No specific educational background or prior experience is required.
MA/MBL11-APAC, Data Analytics Specialist [Intern] at Bosch Group
, , Japan - Full Time
Skills Needed
Data Analytics, Ai Application, Data Management, Data Governance, Python, R, Sql, Machine Learning, Generative Ai, Git, Workflow Automation, Statistics, Engineering, Computer Science, Analytical Mindset, Data Integrity
Specialization
Candidates should be students in Analytics, Statistics, Computer Science, Engineering, or other quantitative fields with a strong foundation in data analytics. Fluency in English is required, with intermediate Japanese or Chinese preferred.
R&D Chemist – Sealants at Sika AG
Hiratsuka, , Japan - Full Time
Skills Needed
Polymer Chemistry, Emulsions, Rheology, Formulating, Waterproofing Membranes, Testing Methods, Manufacturing Processes, Analytical Instruments, Problem Solving, Attention To Detail, Communication Skills, Teamwork, Time Management
Specialization
Candidates must have a Bachelor’s or Master’s degree in Chemistry or a related field, along with 3-5 years of experience in R&D for waterproofing coatings or sealants. Proficiency in Japanese is required, with intermediate English skills preferred.
Experience Required
Minimum 2 year(s)
Production Director at AKQA
Tokyo, , Japan - Full Time
Skills Needed
Production Leadership, Client Management, Budgeting, Risk Management, Creative Collaboration, Vendor Management, Team Leadership, Communication Skills, Film Production, Content Production, Integrated Campaigns, Stakeholder Management, Operational Excellence, Proposal Development, Mentoring, Creative Integrity
Specialization
Candidates should have 8+ years of experience in production leadership roles and a proven track record in delivering large-scale brand and communication projects. Strong experience in film production, content production, and integrated campaigns is essential, along with excellent client-facing skills.
Experience Required
Minimum 10 year(s)
Partnership Manager, APAC at Classiq
Tokyo, , Japan - Full Time
Skills Needed
Partnership Management, Channel Management, Business Development, Strategic Partnerships, Market Penetration, Ecosystem Development, Cross Functional Collaboration, Performance Management, Relationship Building, Negotiation, Conflict Resolution, Technology Landscape Knowledge, Revenue Generation, Sales Alignment, Training And Enablement, Kpi Tracking
Specialization
Candidates should have 7+ years of experience in channel management or strategic partnerships, preferably in the APAC region. A deep understanding of the technology landscape and fluency in Japanese and English are also required.
Experience Required
Minimum 5 year(s)
Quantum Solutions Architect, APAC at Classiq
Tokyo, , Japan - Full Time
Skills Needed
Quantum Computing, Sales, Technical Discovery, Customer Engagement, Quantum Algorithms, Communication Skills, Quantum Software Engineering, Problem Solving, Technical Demos, Cross Functional Collaboration, Machine Learning, Ai
Specialization
Candidates should have 3+ years of experience in a customer-facing technical role and a degree in Computer Science or a related field, with a preference for those with a Ph.D. Excellent communication skills and experience in quantum information or quantum algorithms are also required.
Experience Required
Minimum 5 year(s)
Market HR Partner at NielsenIQ
, , Japan - Full Time
Skills Needed
Human Resources, Talent Management, Employee Relations, Compensation, Compliance, Hr Technology, Data Analysis, Change Management, Diversity, Equity, Inclusion, Communication, Financial Acumen, Organizational Effectiveness, Performance Management, Coaching
Specialization
A bachelor's degree in human resources or a related field is required, along with at least 4 years of relevant HR experience. Strong communication skills in both English and Japanese, as well as knowledge of local laws and HR practices, are essential.
Experience Required
Minimum 5 year(s)
ファイナンス トランザクショナル スペシャリスト at Eurofins
Chiyoda, Nishikanda, Japan - Full Time
Skills Needed
Accounting, Ap, Ar, Expense Reimbursement, Taxation, Project Participation, Team Collaboration, Microsoft Excel, Microsoft Word, Microsoft Powerpoint, Japanese Language, English Language, Interpersonal Skills, Problem Solving, Continuous Improvement, Flexibility
Specialization
Candidates should have 3-5 years of practical experience and possess both independent work capabilities and teamwork skills. Proficiency in Japanese (native or JLPT N1) and English (reading and writing) is required.
Experience Required
Minimum 2 year(s)
Functional Architect at GUIDEWIRE SOFTWARE INC
Tokyo, , Japan - Full Time
Skills Needed
Japanese Language, English Language, Software Development, Consulting, Communication Skills, Leadership, Organizational Skills, Customer Service, Agile Development, Web Application Development, Object Oriented Programming, Cloud Platforms, Data Modeling, Ui/Ux Design, Guidewire Products, Insurance Knowledge
Specialization
Candidates must have over 7 years of experience in software development and consulting, with strong communication and leadership skills. Proficiency in Japanese and English is required, along with technical expertise in web application development and cloud platforms.
Experience Required
Minimum 5 year(s)
NVIDIA platform engineer for Automotive Application / 自動車アプリケーション向けNVIDIAプラ at Quest Global
Kawasaki, , Japan - Full Time
Skills Needed
Nvidia Experience, Orin, Drive Os, Sipl, Qnx, Automotive Industry Experience
Specialization
Candidates must have experience with NVIDIA software, ORIN/Drive OS, SIPL, QNX, and in the automotive industry. Japanese language proficiency at JLPT N2 level or above is required, while English is not mandatory.
Experience Required
Minimum 2 year(s)
Responsibilities Profile at lectrasa
Tokyo, , Japan - Full Time
Skills Needed
Global Account Management, Sales Strategy, Customer Relationship Management, Consultative Selling, Negotiation, Project Management, Software Sales, Saas Business Model, Digital Solutions, Emerging Technologies, Cross Cultural Communication, Team Collaboration, Customer Satisfaction, Risk Management, Industry Trends, Presentation Skills
Specialization
Candidates must have a minimum of 5 years of experience managing large Japanese automotive accounts and a solid background in software sales. Preferred qualifications include experience with digital solutions and a university degree in business or engineering.
Experience Required
Minimum 10 year(s)
Order Management II at Applied Materials
Tokyo, , Japan - Full Time
Skills Needed
Order Management, Customer Service, Sales Orders, Erp Systems, Problem Solving, Communication, Technical Knowledge, Relationship Management
Specialization
Candidates should demonstrate expanded conceptual knowledge in their discipline and possess problem-solving skills. The role does not require supervisory responsibilities but involves providing informal guidance to new team members.
サージカル営業職（大阪） at Alcon
Osaka, , Japan - Full Time
Skills Needed
Sales Experience, Medical Industry Experience, Healthcare Experience, Customer Relationship Management, Surgical Equipment Knowledge, Communication Skills, Problem Solving, Time Management
Specialization
Candidates must have at least three years of sales experience and three years of experience in the medical field, such as nursing or medical engineering. Experience in the healthcare industry is preferred.
Experience Required
Minimum 5 year(s)