At Medtronic, our mission is to alleviate pain, restore health and extend life. We are hiring an Associate Regulatory Operations Specialist to prepare, publish, and deliver paper and electronic regulatory submissions, including e-CTD, for our medical devices. You will ensure compliance and manage regulatory systems within a team dedicated to overcoming obstacles to innovation in a more connected and compassionate world.

What You'll Do

Prepare, publish, perform quality control, and deliver paper and electronic components of all submissions, including initial large marketing authorization applications and electronic common technical documents (e-CTD).
Produce submissions with electronic publishing tools in compliance with document management standards.
Manage activities related to enterprise-wide regulatory management systems, including systems coordination, training, developing and implementing plans, and providing input to systems designs.
Ensure continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
Prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.

What We're Looking For

Bachelor's Degree in Medical/biological science, Engineering, or an equivalent field.
Minimum of 1 year of job experience in a similar role.
Japanese language skills: able to read and write at JLPT N3 level or higher.
Business-level English language skills in reading, writing, and speaking.
Strong attention to detail and accuracy.
Understanding of DMAIC methodology.
Good communication and business writing proficiency.
Scientific knowledge with the ability to read and understand technical documents such as test reports, raw data, and drawings.
Excellent computer skills, including MS Office, Excel (V-lookup), and experience with systems like GTS, Insight, RDR, Ariba, Polaris, and Readsoft.
Regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization.