Regulatory Affairs Operations Specialist Korean Speaker

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 coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.

Responsible for compiling all materials required in submissions license renewal 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.

Required Knowledge and Experience :

Bachelors De gree Required 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 : EnglishBusiness level in reading writing and speaking) Korean (TOPIK II Leve 3 or 4)

Relevant exposure to Project Management and Global Stakeholder Management are ideal (and a plus)

Attention to details and accuracy

Database management and (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 report raw data drawing etc.

Computer skills (excellent knowledge of MS Office Excel (V look) Word computer systems (will use GTS-SAP / Insight / RDR / MAP Agile etc.)

Background in APAC / US / EU 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 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

Required Experience :

IC

Key Skills

Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support

Employment Type : Full-Time

Experience : years

Vacancy : 1