RA/QA Senior Manager

2 weeks 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.

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