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글로벌 Top 진단,의료기기 기업

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Regulatory Affairs Manager

[담당업무]

•Drive, develop and support regulatory strategies and submission plans for South Korea in collaboration with project team, manufacturing sites, supply chain, marketing, country manager anddistributors.
•Work closely with the Legal Manufacturer RA team to ensure the required regulatory submission documents and adequate levelof information is provided in accordance MFDS requirements.
•Manage the preparation and submission of new product registrations, business licenses, permits and amendments including periodic renewals and revisions in accordance with legal/regulatory/compliance requirements, and local business needs.
•Manage the preparation and submission of KC Certifications application and supporting the required testing at applicable laboratory.
•Manage the preparation and maintenance of chemical materialsin accordance with registration and evaluation requirements ofChemicals act and Chemicals Control Act.
•Effectively develop and execute New Health Technology Assessment and reimbursement strategy, support for local clinical study.
•Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.
•Develop, manage and report metrics to track and trend definedKey Performance Indicators for RA South Korea.
•Responsible for review of promotional material for South Korea.
•Develop, motivate and coach and provide guidance to local RA team member,
•Promote awareness of regulatory requirements throughout theorganization.
•Build strong network relationship with the local healthcare policy makers, regulatory agencies and local industry associations.
•Promote teamwork and establish good working relationship atAffiliate level and across the organization
•Perform other activities or special projects as assigned by management or direct supervisor.

[자격요건]

- Bachelor degree or higher degree in Biomedical/MedicalSciences or Engineering.
- A minimum of 5-10 years’ experience in Regulatory Affairs inMedical Devices, preferably in IVDs.

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담당자명 김병천 수석컨설턴트

전화번호 02-6281-5082

www.nterway.com

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