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[Job Description]

Medical RA/QA

POSITION SUMMARY: The Senior Consultant is regularly called upon to act as a regulatory medical device Subject Matter Expert, providing Emergo by UL clients with consulting support and leverages extensive MFDS and Global submission experience as well as familiarity with the MFDS network. Performs work independently, in accordance with written Work Instructions and the stated scope of work and within the agreed upon timeframes established with clients. Acts as Lead Consultant within a team setting.

Provide Quality and Regulatory consulting services which may include but are not limited to:

◆ Conducting training programs / client sessions on quality and regulatory related topics
◆ Provide regulatory consulting services which may include but are not limited to:
1) Compilation of technical documentation to submit to regulatory authorities in accordance with requirements for MFDS MD and IVD registration, as well as US FDA, EU and other markets; gap assessments of existing client documentation
2) Regulatory Pathways (product classification assistance and requirements to bring product to market) for major global markets
3) Pre-Submission and clinical strategy support
4) Clinical Evaluations
5) Prepare meeting requests, and facilitate those meetings (either by teleconference or face-to-face), between clients and the MFDS or other regulatory agencies
◆ As regional SME(Subject Matter Expert), support global clients with guidance regarding medical device classification and regulatory pathways for Korea market entry, as well as assisting with effective regulatory strategies.
◆ Perform quality system assessments and audits for compliance with KGMP, FDA QSRs, ISO 13485:2016, MDSAP, MDR and other specific country regulations.
◆ Standards and awareness training
◆ Perform other regulatory consulting services as requested by our manufacturing clients, and help customize consulting solutions to clients’ specific needs, both on-site and off-site
◆ As an internal SME, participate in developing and maintaining internal Emergo programs and processes for and within the global consulting group
◆ Support, develop and present trainings to colleagues regarding regulations and procedures
◆ Provide guidance to Business Development in determining appropriate scope and budget of proposals, including scoping calls with clients
◆ Review Marketing materials for accuracy, including written documents and website

 

[Job Requirements]

– Bachelor’s degree or equivalent
– 7+ years of Regulatory Affairs and/or Quality Assurance work experience
– A demonstrated knowledge and understanding of medical device quality system requirements (such as KGMP, FDA, QSR, ISO 13485, MDR/IVDR, MDSAP)
– Familiarity with ISO 14971 requirements
– RAC, CQE, CQA (or other quality certification) an advantage
– Auditing experience; lead auditor certification preferred
– Experience writing technical documents; Clinical Evaluation reports a plus (Risk assessment on clinical evaluation)
– Client-facing experience and strong interpersonal skills with the ability to work with all levels of a client’s organization
– Business Fluency in English and Korean, additional languages a plus

 

[Application Guide]

  • 이메일 지원
    – 제출서류: 국문이력서 및 자기소개서, 영문이력서(필수)
    – 접수방법: ​hr.kr@ul.com으로 이메일 접수