Abbott
healthcare
RASpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“RA Specialist at Abbott. Skills: Regulatory Affairs, document packages for regulatory submissions, tracking/control systems, regulatory procedures and changes, regulatory agencies, compliance with regulations. Responsible for the coordination and preparation of document packages for regulatory submissions.. Monitors and improves tracking/control systems.”
What You'll Achieve.
Ensures rapid and timely approval on medical devices and continued approved status of marketed medical devices.
Industry & Context.
Travel: Yes, 5 % of the Time
What They're Looking For.
Must Have
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, quality compliance ethos, Excellent spoken and written of English and local language, Skill to interpret medical devices regulations, pharma-regulations, etc
Nice to Have
Bachelor degree at Science, Life-Science, Life- Engineering, etc. will be an advantage., Experience gained in multinational medical device companies will be beneficial
What You'll Do.
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.
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.
registration/approval etc.
How You'll Work.
Communication Scope
Communication skills; Excellent spoken and written of English and local language
Full Job Description
## **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 & 역삼동_** ** _JOB 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
Applying for this RA Specialist role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Abbott?
Real rants from real employees. Read before you apply.