[Zimmer Biomet Korea] Sr. RA Specialist 경력직 채용

< 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