RA/QA Senior Manager

4 days ago

Manila, National Capital Region, Philippines Terumo Asia Pacific Full time $90,000 - $120,000 per year

About the Company

As a global medical device company originating from Japan, we pursue reliable quality and technology to contribute to healthcare in more than 160 countries and regions around the globe. We promise to walk alongside healthcare professionals to continue to make great contribution to society, now and into the future.

Summary of the Role

This position is responsible for whole RA/QA tasks in TMPI. As a part of the leader team in TMPI, this position has to support the sales revenue from RA/QA viewpoint and ensure that TMPI activities are conducted in compliance with RA/QA relevant regulations, laws, and standards.

Key Functions / Responsibilities

Leadership of RA/QA

  • Establish the objectives and goals of TMPI RA/QA team and ensure success
  • Manage TMPI RA/QA team and keep improving with documentation, standardization, process improvement, etc.
  • Report on RA/QA activities to all stakeholders.
  • Business partnering with regard to RA/QA processes

Obtaining/maintaining product registration

  • Provide regulatory input and strategy to support marketing planning
  • Timely submission and approval with strong communication and negotiation with factory RA and Philippines FDA
  • Maintain product license appropriately (renewal, change)
  • Maintain databases of product licenses and status of product registrations appropriately

Handling user complaints/adverse events/FSCA/recall

  • Vigilance reporting following requirements from Philippine FDA/factories

Keep tracking regulation changes

  • Track regulation change and input to RA/QA in TAP, GHQ, and factories timely
  • Handle the influence of regulation change together with related department and factories to minimize the risk to TMPI

Create a relationship within industry associations and regulatory authorities

  • Establish the network in industry association
  • Discuss current issues, estimated regulation change, etc. within industry association to solve them
  • Take communication with Philippines FDA to obtain regulation update that affect business

Other roles and responsibilities

  • Provide RA/QA related education and training to other department associates, external vendor, service providers, etc.
  • Support sales activities through promotional material review, tender, etc.
  • Monitoring warehouse activity Including local labelling, handling devices, etc.
  • Ad hoc duties as assigned

Functional / Technical Skills

  • At least 10 years of experience in regulatory and QA process in medical device (preferred), pharmaceutical/healthcare industry
    or related fields
  • Expertise in RA/QA preferably in medical device regulation, product registration, post market surveillance and reporting
  • Demonstrated ability to handle product registration, post marketing surveillance and reporting, etc.
  • Demonstrated ability of team management and RA/QA decision making as a representative
  • Ability to work in a matrix organization
  • Good problem solving and leadership skills, self-starter
  • Network in industry association and work as a part of the association

Education and Experience

  • Bachelor's degree or diploma in pharmacy, medical science or related studies

Note to External Recruitment Agencies:

Terumo does not recognize candidate submissions from any recruitment agencies and will not be responsible for payment of any recruitment fees due to the hiring of candidates whose resumes were submitted to Terumo employees or offices without the recruiting team's acknowledgement.

  • Senior QA Engineer

    4 weeks ago

    Manila, National Capital Region, Philippines CashJar Full time

    Join to apply for the Senior QA Engineer (Test Automation) (Remote) role at CashJar.com Overview Lead quality assurance initiatives for the

  • Geotechnical Engineer

    2 weeks ago

    Manila, National Capital Region, Philippines RA International Full time

    OverviewGeotechnical Engineer to lead quality assurance, compliance, and inspection efforts for civil infrastructure projects on Diego Garcia. This hands-on role focuses on geotechnical engineering practices—earthwork, excavation, backfilling, pavement construction, and utility installation—ensuring strict adherence to US standards (USACE, EM 385-1-1),...

  • qa manager

    4 days ago

    Manila, National Capital Region, Philippines GCash Full time ₱1,200,000 - ₱3,600,000 per year

    Do you want to take the first step in making Filipinos' lives better everyday? Here in GCash we want to stay at the forefront of the FinTech industry by creating innovative, meaningful, and convenient financial solutions for the nation G ka ba? Join the G Nation todayTESTING STRATEGY AND EXECUTIONDefine and implement test plans for merchant integration...

  • Senior QA Automation Engineer

    4 days ago

    Manila, National Capital Region, Philippines Crawford & Company Full time ₱900,000 - ₱1,200,000 per year

    A Senior QA Automation Engineer is a talented and dynamic QA automation engineer that is skilled in software testing methodologies and test automation.This QA Automation Engineer takes a contributor role in the design and implementation of software testing strategy, methods, and processes. The engineer will provide experience and guidance to other QA...

  • Senior QA Engineer

    4 weeks ago

    Manila, National Capital Region, Philippines Broadridge Financial Solutions Full time

    Senior QA Engineer (Hybrid) page is loadedSenior QA Engineer (Hybrid)Apply locations Manila Ayala Ave time type Full time posted on Posted 5 Days Ago job requisition id JR1075532At Broadridge, we've built a culture where the highest goal is to empower others to accomplish more. If you're passionate about developing your career, while helping others along the...

  • Senior QA Engineer

    4 days ago

    Manila, National Capital Region, Philippines Aumtrend Full time ₱840,000 - ₱2,160,000 per year

    Role : Senior QA EngineerCompany : One of the global clientLocation : ManilaSetup : HybridJob Description :FLAUI or WinAppDriver experiences is a mustJob Type: PermanentPay: Php70, Php180,000.00 per monthBenefits:Flexible scheduleHealth insuranceLife insuranceApplication Question(s):Exp in to FLAUI or WinAppDriverMay we check Current Salary , Expected Salary...

  • Manager – QA, Delivery and Business Analysis

    4 weeks ago

    Manila, National Capital Region, Philippines Aurecon Full time

    Manager – QA, Delivery and Business AnalysisThe role manages three key delivery capability functions – Quality Assurance (QA Engineers / Testers), Project Management (Delivery Owners), and Business Analysis (Scrum Masters). The role is responsible for aligning these disciplines to deliver customer and business value, through modern, Agile and hybrid...

  • QA Manager

    2 days ago

    Manila, National Capital Region, Philippines MedGrocer Full time ₱900,000 - ₱1,200,000 per year

    MedGrocer's digitally-enabled medicine programs, telehealth services, and corporate clinic medical staff work with hundreds of employers and pharma companies to improve the physical and mental health of over one million Filipinos every year.TheQA Managerleads the quality assurance team in creating and executing comprehensive test plans to identify issues...

  • Senior QA

    4 hours ago

    Manila, National Capital Region, Philippines Private Advertiser Full time ₱1,200,000 - ₱2,400,000 per year

    Job Description: Quality Assurance Analyst (Mobile Games & Apps)Are you a meticulous and detail-oriented professional with a passion for mobile technology and games? We are seeking a talented Quality Assurance Analyst to join our team and help us deliver exceptional experiences to our users.As a QA Analyst, you will be responsible for testing Android games...

  • Senior QA Automation Engineer

    4 days ago

    Manila, National Capital Region, Philippines Earthtrack Full time ₱1,500,000 - ₱3,000,000 per year

    As a QA Automation Engineer at EarthTrack, you will take ownership of establishing and evolving our QA processes. Working closely with the CTO, Technical Lead, and Development team, you will not only design and maintain automation frameworks but also set the direction for how quality is embedded into our development lifecycle.This role requires both hands-on...