About the Role

As part of the Instrument Services team, you will take ownership of cases assigned, driving & delivering high quality service resolution; provide timely onsite support to address service repair issues at customer sites according to contract prioritization. Ensure the timely completion of all required service documentation. Follow up with customers regarding instrument performance post service intervention. Communicate proactively and share information with field team members, Service Operation team, Technical Service and Customer Service teams, in addition to other support functions to ensure the success of 10x Genomics.

As a Field Service Engineer, you will perform assembly, disassembly, and repair work on analytical laboratory instruments and equipment. Effectively and safely utilize test equipment, hand tools and power tools when needed. 

You’ll be responsible for documentation as required by company policy, cGMP, ISO, Regulatory agencies and support the loading and updating of software, calibrations, preventive maintenance, and Pre-staging of new equipment. Additionally, you will also monitor personal parts stock, test equipment and test tools inventory to ensure proper levels and current calibration certificates are readily available for typical servicing of instruments. Conduct advanced, complex service tasks and instrument configurations.

You’ll actively contribute to the Service Knowledge Base and support increased utilization of the knowledge management database. Recommend methods to improve field service efficiency and identify opportunities to improve overall service delivery processes, remote tools, support capabilities, and customer satisfaction.

What you will be doing

• Test, troubleshoot, and repair instruments and equipment to the Field Replaceable Unit (FRU) level
• Analyze complex situations and apply independent judgment when resolving problems
• Interpret past repairs on analytical laboratory instruments to resolve and diagnosis new highly complex issues
• Assemble and disassemble instruments and equipment
• Support Pre-staging of instruments to ensure full functionality prior to Sales Inventory transfer
• Perform electronic, mechanical, pneumatic, programmable logic controllers, liquid, gas, fluidics, and electrical repairs associated analytical laboratory instruments and equipment
• Provide field based on the job training for Field Service Engineers on the proper preventive maintenance, calibration, and service techniques for analytical laboratory instruments
• Responsible for supporting upgrade release activities including calibration and configuration of analytical laboratory instruments
• Monitor personal inventory levels to ensure adequate levels of parts and supplies are available on hand, if not place orders for supplies following company procedures

 Minimum Requirements    

• Bachelor’s degree in Biomedical Engineering / Technology (or equivalent)
• Multi-year experience with the service and repair of analytical laboratory instruments
• Demonstrated ability to operate independently and manage multiple priorities

• Understanding of critical customer experience factors and after sales service
• Excellent customer facing communication and interpersonal skills
• Detail oriented and able to effectively collaborate within a cross functional team
• Excellent time management skills, with a focus on effective scheduling, prioritization, delegation, and the ability to coordinate and address competing demands
• Fluent Japanese and English language skills written and spoken
• Ability to travel as required within the APAC region to be successful in this field-based role, expected to be at least 65% of the time

Preferred Qualifications and/or Experience

• Proficiency in Microsoft Suite, in particular Excel and PowerPoint
• Familiarity with microfluidic systems
• Experience working with optical systems
• Working knowledge of Linux operating system

#LI-DM1

#LI-REMOTE

About the Role

As part of the Instrument Services team, you will take ownership of cases assigned, driving & delivering high quality service resolution; provide timely onsite support to address service repair issues at customer sites according to contract prioritization. Ensure the timely completion of all required service documentation. Follow up with customers regarding instrument performance post service intervention. Communicate proactively and share information with field team members, Service Operation team, Technical Service and Customer Service teams, in addition to other support functions to ensure the success of 10x Genomics.

As a Field Service Engineer, you will perform assembly, disassembly, and repair work on analytical laboratory instruments and equipment. Effectively and safely utilize test equipment, hand tools and power tools when needed. 

You’ll be responsible for documentation as required by company policy, cGMP, ISO, Regulatory agencies and support the loading and updating of software, calibrations, preventive maintenance, and Pre-staging of new equipment. Additionally, you will also monitor personal parts stock, test equipment and test tools inventory to ensure proper levels and current calibration certificates are readily available for typical servicing of instruments. Conduct advanced, complex service tasks and instrument configurations.

You’ll actively contribute to the Service Knowledge Base and support increased utilization of the knowledge management database. Recommend methods to improve field service efficiency and identify opportunities to improve overall service delivery processes, remote tools, support capabilities, and customer satisfaction.

What you will be doing

• Test, troubleshoot, and repair instruments and equipment to the Field Replaceable Unit (FRU) level
• Analyze complex situations and apply independent judgment when resolving problems
• Interpret past repairs on analytical laboratory instruments to resolve and diagnosis new highly complex issues
• Assemble and disassemble instruments and equipment
• Support Pre-staging of instruments to ensure full functionality prior to Sales Inventory transfer
• Perform electronic, mechanical, pneumatic, programmable logic controllers, liquid, gas, fluidics, and electrical repairs associated analytical laboratory instruments and equipment
• Provide field based on the job training for Field Service Engineers on the proper preventive maintenance, calibration, and service techniques for analytical laboratory instruments
• Responsible for supporting upgrade release activities including calibration and configuration of analytical laboratory instruments
• Monitor personal inventory levels to ensure adequate levels of parts and supplies are available on hand, if not place orders for supplies following company procedures

 Minimum Requirements    

• Bachelor’s degree in Biomedical Engineering / Technology (or equivalent)
• Multi-year experience with the service and repair of analytical laboratory instruments
• Demonstrated ability to operate independently and manage multiple priorities

• Understanding of critical customer experience factors and after sales service
• Excellent customer facing communication and interpersonal skills
• Detail oriented and able to effectively collaborate within a cross functional team
• Excellent time management skills, with a focus on effective scheduling, prioritization, delegation, and the ability to coordinate and address competing demands
• Fluent Japanese and English language skills written and spoken
• Ability to travel as required within the APAC region to be successful in this field-based role, expected to be at least 65% of the time

Preferred Qualifications and/or Experience

• Proficiency in Microsoft Suite, in particular Excel and PowerPoint
• Familiarity with microfluidic systems
• Experience working with optical systems
• Working knowledge of Linux operating system

#LI-DM1

#LI-REMOTE

Position Summary

The Device Regulatory Senior Manager will work together with Global Regulatory Affairs to lead the regulatory strategy and documentation management from Device product perspectives to facilitate the submission processes for the development, approval, and commercialization of medical devices in the U.S. and other global market. This position requires a deep understanding of FDA regulations, as well as expertise in navigating the requirements of medical device development and regulatory compliance. The ideal candidate will ensure timely and successful regulatory submissions, manage relationships with regulatory agencies, and provide strategic guidance to cross-functional teams, including Regulatory Affairs department at Rakuten Medical.

Key Roles and Responsibilities

• Develop and Implement Device Product Regulatory Strategy: Create and execute regulatory strategies for new product development, approval, and lifecycle management, ensuring alignment with company goals and regulatory requirements including U.S. FDA, CE marking.
• Regulatory Submissions: Oversee and prepare high-quality regulatory submissions (e.g., 510(k), PMA, IDE, and De Novo applications) and manage the process from pre-submission meetings to final approvals.
• Regulatory Compliance and Documentation: Ensure compliance with U.S. FDA regulations (21 CFR Part 820), Quality System Regulations (QSR), CE marking and other applicable guidelines and standards (ISO 13485).
• Regulatory Intelligence and Risk Assessment: Conduct regulatory assessments and stay updated on changes in requirements, e.g., FDA regulations and guidance, analyse their impact on current and future projects.
• Cross-functional Collaboration: Provide regulatory guidance and training to R&D, clinical, marketing, and quality teams to integrate regulatory requirements into product development and commercialization plans.
• Agency Interaction: Work with Global Regulatory Affairs to serve as the liaison with the FDA and other regulatory agencies, managing agency interactions, responses to inquiries, and ongoing regulatory requirements.
• Team Leadership: Work with Global Regulatory Affairs and Device Technical team to establish best practices and maintain high standards in regulatory processes.

Desired Education, Skills and Experience

• Education
  • Bachelor’s Degree in Life Sciences, Engineering, or a related field.
  • Advanced Degree (Master’s, Ph.D., or JD) in Biomedical Engineering, or a relevant scientific discipline is preferred.
• Skills/expertise
  • In-depth Knowledge of Medical Device Regulations & Requirements, including FDA Regulations. Strong expertise in 21 CFR Part 820 (QSR), ISO 13485, and FDA guidance on medical devices.
  • Technical Writing and Documentation: Exceptional skills in preparing regulatory documentation and understanding technical data for submission.
  • Analytical and Strategic Thinking: Ability to assess regulatory risks, interpret regulatory requirements, and develop actionable strategies for complex regulatory challenges.
  • Project Management: Strong organizational skills with the ability to manage multiple projects and meet regulatory deadlines.
  • Leadership and Communication: Demonstrated leadership skills with the ability to communicate effectively with cross-functional teams and regulatory agencies.
  • Regulatory Certification (Preferred): RAC (Regulatory Affairs Certification) or equivalent certification is a plus.
  •  Preferred skills:
    • Familiarity with global regulatory requirements, including EU MDR, MDSAP, and other international regulatory frameworks.
    • Knowledge of emerging regulatory trends and digital health regulations, including software and AI-based medical devices.
    • Experience with investigational device exemptions (IDEs)
    • Experience in communicating in English with business partners and the ability to read, write, and speak in English is required
• Experiences
  • 10+ years of experience in regulatory affairs, 5+ years within the medical device industry, with a strong focus on the regulation requirements in major jurisdictions, e.g., U.S. FDA, CE marking.
  • Proven track record of successful regulatory submissions and product approvals in the major jurisdictions (e.g., 510(k), PMA).
  • Experience with Class III or higher medical devices is preferred; familiarity with combination products or software as a medical device (SaMD) is a plus.
  • Experience in managing cross-functional projects.

Required Documents:

Please submit your resume (履歴書and職務経歴書) in Japanese and CV in English.