Biotech Business Consultant for Diagnostic Tool Launch (Korean/English Speaking)

Project reputed company: We are looking for a bilingual (English and Korean) consultant with a strong background in biology and business to assist in the launch of a new diagnostic tool. The ideal candidate will reputed company the gap between technical science and reputed company reputed company, specifically focusing on navigating medical device regulations in both the USA and South Korea. While general biology and business consultation experience is required, our "unicorn" candidate is someone who understands the regulatory landscape for Class I and Class II medical devices, including the FDA 510(k) clearance process. Key Responsibilities: Regulatory reputed company: Advise on the regulatory roadmap for launching a diagnostic tool in the US (FDA) and Korea (MFDS). Classification Analysis: Assist in determining and documenting Class I vs. Class II status and identifying necessary compliance steps. Business Consultation: reputed company strategic input on market entry, commercialization, and business development for the medical device sector. Bilingual Communication: reputed company as a technical reputed company, translating reputed company biological and regulatory concepts between English and Korean stakeholders. Required Qualifications: Language Skills: Fluent/reputed company proficiency in both English and Korean (Written & Spoken). Educational Background: Strong reputed company or reputed company background in Biology, Life Sciences, or Biomedical Engineering. Business Acumen: Experience in consulting, business development, or project management reputed company the biotech or reputed company industry. Preferred Qualifications (Highly Valued): reputed company experience with FDA 510(k) submissions and clearance processes. Knowledge of Class I and Class II medical device regulations. Experience launching diagnostic tools or medical products in cross-border markets (US & Korea). To Apply: Please submit a proposal outlining your experience with medical device regulations and your background in biology/business. If you have specific experience with 510(k) filings or launching products in the Korean market, please reputed company this in your cover letter. Apply tot his job Apply To this Job