regulatory operations specialist ( Japanese Speaker)Medtronic Cardiac and Vascular
Workplace: Taguig
Salary: Agreement
Work form: Full time
Posting Date: 16/06/2025
Deadline: 10/08/2023
Job Description
Careers That Change Lives
Bold thinking. Bolder actions. We are Medtronic.
Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let's work together to address the universal healthcare needs and improve patients lives, optimize costs and efficiencies, and expand global access. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
A Day in the life
Responsibilities may include the following and other duties may be assigned.
Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD).
Submissions are produced with electronic publishing tools in compliance with document management standards.
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Must Have
Bachelors degree required
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Your Profile
Bachelor's Degree Required in Medical/ biological science/ Engineering or equivalent field.
Language skills Japanese/English Communication skills, (Japanese: able to read and write words in Japanese (JLPT N3 level or up N1N5: | JLPT, English:Business level in reading, writing and speaking)
Minimum of 2 years of relevant experience
Attention to details and accuracy
Database management
Good communication skills
Scientific knowledge, must be able to read and understand the technical document such as test report, raw data, drawing etc.
Computer skills (excellent knowledge of MS Office, Excel (V look), Word , computer systems (will use GTS/Insight/RDR/Ariba/Polaris/Readsoft)
Regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization
Background in Japanese Medical Device Regulation is a plus
Minimum of 3 years of job experience in similar role is preferred
Careers That Change Lives
Bold thinking. Bolder actions. We are Medtronic.
Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let's work together to address the universal healthcare needs and improve patients lives, optimize costs and efficiencies, and expand global access. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
A Day in the life
Responsibilities may include the following and other duties may be assigned.
Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD).
Submissions are produced with electronic publishing tools in compliance with document management standards.
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Must Have
Bachelors degree required
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Your Profile
Bachelor's Degree Required in Medical/ biological science/ Engineering or equivalent field.
Language skills Japanese/English Communication skills, (Japanese: able to read and write words in Japanese (JLPT N3 level or up N1N5: | JLPT, English:Business level in reading, writing and speaking)
Minimum of 2 years of relevant experience
Attention to details and accuracy
Database management
Good communication skills
Scientific knowledge, must be able to read and understand the technical document such as test report, raw data, drawing etc.
Computer skills (excellent knowledge of MS Office, Excel (V look), Word , computer systems (will use GTS/Insight/RDR/Ariba/Polaris/Readsoft)
Regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization
Background in Japanese Medical Device Regulation is a plus
Minimum of 3 years of job experience in similar role is preferred
Submit profile
Medtronic Cardiac and Vascular
About the company
Medtronic Cardiac and Vascular jobs
Taguig ,
Associate Regulatory Affairs Software Development Specialist
Medtronic
MetroManila, Manila, TaguigAgreement
Position regulatory operations specialist ( Japanese Speaker) recruited by the company Medtronic Cardiac and Vascular at Taguig, Joboko automatically collects the salary of , finds more jobs on Regulatory Operations Specialist (Japanese Speaker) or Medtronic Cardiac and Vascular company in the links above
About the company
Medtronic Cardiac and Vascular jobs
Taguig ,