Partner Websites

RA Specialist


  • Medical & Health Care Jobs
  • Marketing Jobs
  • Financial Services
  • Manufacturing Jobs
  • Save Ad
  • Email Friend
  • Print

Job Details

RA Specialist


Seoul, Seoul, Korea

Requisition #:


Post Date:

5 days ago

**Careers that Change Lives**

Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Are you looking for the opportunity to be on the cutting edge of medical devices regulatory affairs?

**A Day in the Life**

We are looking for a Regulatory Affairs Specialist, based in our Glass Tower, Seoul Office. This is a unique opportunity to join the Regulatory Affairs Team to ensure the appropriate licensing, marketing and legal compliance of a range of our medical devices in order to control their safety and efficacy. You will be an experienced Regulatory Affairs Specialist, having had at least 3 years relevant experience within medical devices/ Pharma. It is a wonderful opportunity over time, to take your monitoring career towards your career growth in medical technology and device research.

**Position Description**

Responsibilities may include the following and other duties may be assigned.

+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

+ Leads or compiles all materials required in submissions, license renewal and annual registrations.

+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

+ Monitors and improves tracking / control systems.

+ Keeps abreast of regulatory procedures and changes.

+ May direct interaction with regulatory agencies on defined matters.

+ Recommends strategies for earliest possible approvals of clinical trials applications.

**Must Have: Minimum Requirements**

+ University Degree

+ Minimum of 3years of relevant experience

**Your Profile**

+ Bachelors Degree Required in Medical/ biological science or equivalent field

+ Prior experience in a Regulatory Affairs role is essential, with 3 to 4 years of relevant experience

+ Excellent stakeholder relationship management

+ Outstanding communication and interpersonal skills

+ Strong ability to work well within a team and autonomously

+ Achievement oriented and ability to drive results with the highest quality standards

+ Computer skills (excellent knowledge of MS Office products).

+ High attention to detail and accuracy

+ Good prioritization and organizational skills.

+ Excellent problem-solving skills

+ Bi-lingual proficiency in English and Korean language

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

**Physical Job Requirements**

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
© 2013. PennWell Corporation. All Rights Reserved. PRIVACY POLICY | TERMS AND CONDITIONS | SITE MAP | CONTACT US | PennWell Websites | PennWell Events