Biotech Business Consultant for Diagnostic Tool Launch (Korean/English Speaking)
Project Overview: 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 bridge the gap between technical science and commercial strategy, 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 Strategy: 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: Provide strategic input on market entry, commercialization, and business development for the medical device sector. Bilingual Communication: Act as a technical bridge, translating complex biological and regulatory concepts between English and Korean stakeholders. Required Qualifications: Language Skills: Fluent/Native proficiency in both English and Korean (Written & Spoken). Educational Background: Strong academic or professional background in Biology, Life Sciences, or Biomedical Engineering. Business Acumen: Experience in consulting, business development, or project management within the biotech or healthcare industry. Preferred Qualifications (Highly Valued): Direct 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 highlight this in your cover letter.