Roche
Regulatory Affairs Specialist
Overview
Develop and execute regulatory strategies for timely market access in Korea, leading the preparation and submission of high-quality dossiers to the MFDS.
About Roche
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
Requirements & Eligibility
- Bachelor's degree or higher in a relevant scientific field
- Minimum of 2 years of RA experience in the Korean medical device/IVD industry
- Expert knowledge of MFDS MD/IVD/Digital Medical Product regulations
- Exceptional written and verbal communication skills in both Korean and English
Key Responsibilities
- Develop and execute regulatory strategies for timely market access in Korea, leading the preparation and submission of high-quality dossiers to the MFDS
- Ensure timely submissions and approvals by preparing high-quality regulatory applications in line with planned or committed timelines
- Monitor the Korean regulatory landscape, interpret new regulations, and serve as the primary communication contact with the MFDS
- Act as the RA expert on project teams, collaborating effectively with global, APAC & local stakeholders
- Apply expert knowledge of clinical performance evaluation in compliance with ISO 20916 and MFDS regulations
Interview Process
서류 전형▶ 면접 전형 ▶ 종합 심사 ▶ 최종 합격 통지
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