Associate Regulatory Operations Specialist - Japanese Speaker at Medtronic

Taguig City, National Capital Region, Philippines

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor's Degree in Medical/Biological Science/Engineering or equivalent field
Minimum of 1 year job experience in a similar role
Language skills: Japanese (able to read and write; JLPT N3 level or higher) and 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; able to read and understand technical documents such as test reports, raw data, drawings
Computer skills: excellent knowledge of MS Office, Excel (VLOOKUP), Word; computer systems (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 (preferred)

Responsibilities

Preparation, publication, quality control, and delivery of paper and electronic components of all submissions, including initial large marketing authorization applications and e-CTD, using electronic publishing tools in compliance with document management standards
Activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs
Ensuring continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors
Preparing, submitting, tracking, indexing, and archiving paper and electronic submissions, including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials
Other duties as assigned

Skills

Regulatory Submissions

e-CTD

Japanese JLPT N3

English Business Level

MS Office

PDF

DocuSign

SharePoint

DMAIC

Document Management

Quality Control

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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