Regulatory Affairs Operations Specialist - Korean Speaker at Medtronic

Taguig City, National Capital Region, Philippines

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, PharmaceuticalsIndustries

Requirements

Bachelor's Degree in Medical/Biological Science/Engineering or equivalent field
Minimum of 3 years of job experience in similar role and/or discipline
Regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization
Language skills: English (Business level in reading, writing, and speaking), Korean (TOPIK II, Level 3 or 4)
Attention to details and accuracy
Database management (Familiarity with Regulatory Systems/Tools is a plus)
Good communication skills and data presentation
Business writing proficiency and standard applications like MS Office, PDF, SharePoint
Good understanding of DMAIC methodology
Scientific knowledge, must be able to read and understand technical documents such as test reports, raw data, drawings, etc
Computer skills (excellent knowledge of MS Office, Excel (VLOOKUP), Word, computer systems like GTS-SAP/Insight/RDR/MAP Agile, etc.)
Background in APAC/US/EU Medical Device Regulation is a plus
Relevant exposure to Project Management and Global Stakeholder Management are ideal (and a plus)

Responsibilities

Coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections
Compiling all materials required in submissions, license renewals, and annual registrations
Recommendations for labeling for regulatory compliance
Monitors and improves tracking/control systems
Prepares, submits, tracks, indexes, and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials
Keeps abreast of regulatory procedures and changes
May direct interaction with regulatory agencies on defined matters
Recommend strategies for earliest possible approvals
Ensures continuous efficiency and effective process improvement measurements

Skills

Regulatory Submissions

Document Coordination

Labeling Compliance

Regulatory Tracking

Electronic Submissions

Adverse Event Reporting

Project Management

Global Stakeholder Management

Database Management

MS Office

SharePoint

DMAIC

Business Writing

Korean Language

TOPIK Level 3-4

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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