At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

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.

Required Knowledge and Experience:

• Bachelors Degree Required in Medical/ biological science/ Engineering or equivalent field.

• Minimum of 1 year job experience in similar role

• Language skills Japanese/English Communication skills (Japanese: able to read and write words in Japanese (JLPT N3 level or up N1N5:認定の目安 日本語能力試験JLPT EnglishBusiness level in reading writing and speaking)

• Attention to details and accuracy

• Understanding of DMAIC methodology

• Good communication skills

• Business writing proficiency and standard applications like MS Office PDF DocuSign Sharepoint

• 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

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here