Associate Regulatory Operations Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll 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:

• Bachelor's 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 N1~N5:認定の目安 | 日本語能力試験 JLPT, English:Business 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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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 95,000+ 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