RA Specialist

JOB DESCRIPTION:

ABOUT ABBOTT:

At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love.
With global headquarters in Chicago, USA, we serve people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. Our 115,000 colleagues are helping millions of people to live better and healthier, every day around the world. In South Korea, we’ve been helping people live fully for more than 30 years.

Location: 대치동 & 역삼동JOB PURPOSE AND SCOPE:

• Responsible for the coordination and preparation of document packages for regulatory submissions.
• Monitors and improves tracking/control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Ensures rapid and timely approval on medical devices and continued approved status of marketed medical devices.
• Ensures compliance with regulations and interpretations

MAIN RESPONSIBILITIES:

• Compiles all materials required in submissions and license renewal.
• Coordinates and maintains reporting schedules for product licensing application notices.
• Interacts with regulatory agency personnel in order to expedite approval of pending applications.
• Compliance Work, procedures, employee trainings, promo materials, registration/approval etc.

MINIMUM SKILLS REQUIRED:

• Understanding of Regulatory Affairs in Medical Device
• Organized with a high attention to detail
• Skill to conduct multiple tasks at the same time
• Communication skills
• Customer responsiveness to needs of commercial operations
• Strong quality compliance ethos
• Excellent spoken and written of English and local language
• Bachelor degree at Science, Life-Science, Life- Engineering, etc. will be an advantage.
• Skill to interpret medical devices regulations, pharma-regulations, etc

EXPERIENCE REQUIRED:

• Bachelor Degree : 2 to 4 years of relevant experience (general electronic science/Biology/Biomed degree)
• Experience gained in multinational medical device companies will be beneficial

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

MD Medical Devices:

LOCATION:

Korea > Seoul : Sam Tan Building, 421 Youngdong-daero, Gangnam-gu

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable