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Job Title:  Regulatory Affairs Specialist

Req ID:  30190
Job Category:  Regulatory Affairs

Seoul, 11, KR, 000000

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

Reporting to the Regulatory Affairs and Compliance Manager, within the RA Department, the incumbent is responsible for supporting the development and administration of STERIS’s global regulatory policy positions across product lines of the STERIS businesses by preparing international regulatory submissions for STERIS (and its affiliates) product approvals and the works to meet S. Korea post market surveillance requirements. The Incumbent will also provide support for plans to achieve identified corporate regulatory policy objectives, . Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or STERIS’s business directly.

Duties

1.      Identify regulatory requirements for new products or product enhancements early in the product development cycle. Collect Regulatory Intelligence for S. Korea.

2.      Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims. Coordinate compulsory test in S. Korea when there is the need.

3.      Review product revision requests to assure compliance with regulatory requirements. Assess new product launch requirements and provide the regulatory information according to the needs

4.      Work on product teams to develop regulatory strategy based on regulatory submission requirements.

5.      Review and approve labeling and marketing literature, as needed. Work together with UDI team to comply with S. Korea UDI requirements.

6.      Support Regulatory Affairs and Compliance Manager and other Regulatory Affairs staff with all regulatory and compliance matters. Conduct timely activities of Supervisor assigned.

7.      Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management.

8.      Lead the Recall and Adverse Event reporting in S. Korea. Work with Compliance team and follow the regulation for Recall and AE reporting.

9.      Archive all paper and electronic submission documents properly.

10.       Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.

Duties - cont'd

Education Degree

Bachelor's Degree

Required Experience

  • 1-3 years solid experience with good track record in S. Korea Regulatory Affairs professions.
  • Fluent English in speaking and writing. English communication is necessary required.
  • Familiar with the standards and regulations of MFDS. Work in Medical Device related company and have the experience for Medical Device registration.
  • Positive working attitude and responsive.
  • Meticulous, precise and analytical.
  • A self-starter and able to work independently with minimum supervision.
  • Good organizational, time management, project management, and problem solving skills.
  • Excellent communication skill and a good team player.
  • Proficiency in English.
  • Able to work under time pressure to meet deadlines and accept sometime overtime work for join in conference call.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  30190
Job Category:  Regulatory Affairs

Seoul, 11, KR, 000000


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