담당업무

Accountability 1: Regulatory Champion/Representative

? Provide critical regulatory timelines to support accurate planning, forecasting and

budgeting for Korea Markets

? Lead a culture of business (code of conduct)/regulatory (local legislation) compliance in Korea

and provide guidance and support to the Cochlear team and distributor team members to

ensure compliance

Accountability 2: Regulatory Product Registrations

? Implement product registration plans and communicate status to relevant stakeholders to

deliver timely product submissions and approvals

? Establish and maintain regulatory files and licenses in a format consistent with legislative

requirements and business requirements

? Build and maintain relationships with relevant industry associates, regional regulatory

authorities in Korea and Cochlear global teams

? Support or manage regulatory submissions and approvals in other countries in APAC

as required by the business, from time to time

? Facilitate communication with applicable regulatory agencies and authorities during

ongoing review of submissions.

? Follow up all submissions and post-approval commitments and renewal activities in a

timely manner

Accountability 3: Quality Management System

? As the Quality representative for Korea, fulfil all requirements related to the quality function in

partnership with the Global and APAC Regional teams

? Establish and maintain a Quality Management System that supports operational excellence

and achieves Good Importation Practice (GIP) in Korea, as required

? Manage to maintain and renew the Good Manufacturing Practice (GMP) certification through

collaboration with the Global and APAC QA team

? Manage quality related issues and mandatory reporting to the health authority

Accountability 4: Surveillance and Compliance

? Review sales and marketing literature and product labelling for approved product claims and

regulatory compliance

? Partner with the Korea Marketing team to develop marketing collateral and procedures that

are complaint with regulatory standards

? Participate in Cochlear’s post market surveillance system and ensure that it is compliant with

Korea’s regulatory requirements

스킬

ㆍRA

자격요건

ㆍ학력 : 대졸이상

ㆍ경력 : 경력6년↑

자세한 내용은 담당자에게 문의를 요청하시면 빠르게 안내받으실 수 있습니다.
헤드헌팅팀  PM김유선  YOU SUN KIM
M. 010.4571.3074 E. yous.kim@dramancompany.com