Sr. Regulatory Affiars Specialist 정규직 1명
< Job Function > Regulatory Affairs/Quality/Reimbursement
< Job Summary >
Responsible for leading the regulatory, quality, and reimbursement functions.
< Principal Duties and Responsibilities >
* New product registration & Maintenance of existing product licenses
- Product registration - License maintenance – ECN, Renewal - Communication and alignment with the global regulatory team to receive support for local product registration and management of local regulatory systems and processes - Updating documentation for registration information (e.g., registration master file, SharePoint master file, distribution registration folder) -Providing product registration status and results to the business team and related parties to aid in their planning and preparation; working collaboratively with the business team to identify and resolve registration and quality issues for operational effectiveness.
* Compliance with MFDS & Corporate QA requirement
-KGMP maintenance e.g. on-site audit and document audit
- Preparation of Korean labeling documents; Korean IFU & Korean label - Prepare/revise/control QM, PD and SOP to ensure compliance with the Corporate and the MFDS requirements for Korea operations - Tracking and following up on new regulations/requirements
* Market Access - Reimbursement price listing and nHTA submission for a new product
< Expected Areas of Competence (i.e. KSAs) >
- Competent English language skills (reading, writing, listening, and speaking)
- Comprehensive knowledge of MFDS regulations
- Strong writing and communication skills; ability to communicate effectively at multiple levels including with regulatory authorities
- Knowledge of medical device products and regulations and ability to interpret them
- Ability to manage multiple projects
- Responsible, professional, detail-oriented
- Strong computer skills
< Education/Experience Requirements >
- Bachelor’s Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred - Minimum of 6-7 years of experience required in Regulatory Affairs and/or Quality - Certifications an advantage including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC
< Travel Requirements >
- No reason for disqualification for oversea travels
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