RA/QA Senior Manager

1 day 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 Manager

    1 day ago

    Manila, National Capital Region, Philippines iScale Solutions, Inc. Full time $90,000 - $120,000 per year

    We are looking for a highly organized and strategic Senior QA Manager - Program Management to lead the planning and execution of internal QA projects as well as cross-functional initiatives that span multiple pods. This role plays a key part in driving alignment across the QA organization, increasing visibility into ongoing initiatives, and ensuring...

  • Senior QA Engineer

    1 day ago

    Manila, National Capital Region, Philippines iSupport Worldwide Full time $90,000 - $120,000 per year

    Be a part of our fast-growing team and unchain all the possibilities What is your mission? We are looking for a highly skilled and proactive Senior QA Engineer to join our agile squad focused on delivering a next-generation digital onboarding experience. In this role, you will lead the planning and execution of robust test strategies across key customer...

  • Senior QA Engineer

    4 days 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

  • QA Coach

    3 weeks ago

    Manila, National Capital Region, Philippines Helloconnect Full time

    About the job QA Coach - Non Eng (IJP - Manila)General ResponsibilitiesThe role of the QA Coach is to instill a high level of customer care standards within our team, with the aim to improve our customer satisfaction. Each and every customer touch point should shine ensuring our customers only speak positively about their experience with the customer care...

  • Senior QA Automation Engineer

    1 day ago

    Manila, National Capital Region, Philippines Crawford & Company Full time $90,000 - $120,000 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

    1 day ago

    Manila, National Capital Region, Philippines Aumtrend Full time ₱1,680,000 - ₱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...

  • Senior QA Engineer

    2 days 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...

  • qa manager

    1 day ago

    Manila, National Capital Region, Philippines GCash Full time ₱900,000 - ₱1,200,000 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...

  • Manager – QA, Delivery and Business Analysis

    5 days 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 Lead

    1 day ago

    Manila, National Capital Region, Philippines Booth and Partners Full time $90,000 - $120,000 per year

    About the Client:They started Vehlo in 2019 with a simple goal: to be the industry's favorite provider of repair shop technologyInstead of going it alone, they brought together the industry's disruptors–solutions like Text2Drive, Shop Boss, and Rapid Recon– to improve the vehicle repair experience from the dealership service lane to the aftermarket...