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RA Associate (Temporary) Job

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Date: Sep 2, 2021

Location: Kangnam-gu, 11, KR

Company: Boston Scientific

An exciting opportunity 

Boston Scientific Korea is seeking an initiative and responsible Regulatory Affairs (RA). Our mission is to transform lives through innovative medical solutions that improve the health of patients. Boston Scientific Korea RA team plays an important role to introduce various innovative medical solutions in order to improve the quality of patient lives. If you want to develop your RA competency and contribute to improving the quality of patient lives, please join us.

 

Purpose Statement

Maintain product licenses as per relevant regulations in order to keep business continuity and support business growth.

 

 

Key Responsibilities

  • License Gap Analysis: Review licenses based on current regulations and IFUs and then, if required, update licenses accordingly per plan agreed with a RA manager or designees.
  • Maintain regulatory files and databases as per SOP. Update the internal system to reflect changes and to support the import system.
  • Update labels and IFUs accordingly after completing product approval to be compliant with the regulation.

 

Basic Requirements

  • Requires a BA degree in a science or a related field.
  • 1 ~ 2 years of relevant working experience within the regulatory affairs discipline.
  • Good verbal and written communication skills in English.

 

Preferable Requirements

  • Positive attitude and strategic thinking.
  • Interpersonal and organizational skills.
  • Experience in negotiating with regulatory authorities.

 

Required System Skills

  • Good computer proficiency (Hangeul, MS Office) preferred.


Job Segment: Medical, Law, Temporary, Compliance, Regulatory Affairs, Healthcare, Legal, Contract