Research Scientist/Regulatory Affairs Specialist
Research Scientist/Regulatory Affairs Specialist, Independently perform experiments and procedures with a higher degree of complexity demonstrating increasing expertise with a wide range of techniques. Conduct technical tasks with expertise in various types of assay development and optimization with enzymes, reagent formulations and chemicals and lead projects with minimal supervision. Present results within lab, at project meetings, as well as for other internal parties as needed. Research, collect data, and respond to requests from regulatory agencies to prepare and submit documentation for marketing approvals which include 510K'S, clia, otc (US, Canada and EU), as well as to provide routine regulatory information to associates and affiliates. Provide regulatory guidance to product development teams and responds to product information requests. Represent regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion. Lead technical investigations and risk assessments for product, materials and process changes and collaborate in development of regulatory strategies and authoring FDA submission related documents. Conduct and supervise any clinical trials and get approvals from IRB by serving as principal investigator. Assist in the development of best practices for regulatory affairs. Processes and provide regulatory affairs support during internal and external audits. Create and maintain design history file (dhf), protocols, quality system documentation, technical files and plan follow-up and contribute to the design of the product. Represent Teco Diagnostics at medical conferences and expo-meetings to perform presentations and meet prospective clients. May have additional organizational responsibilities (e.g., mentoring of interns, lab coordination responsibilities). React to evolving project priorities and provide independent interpretation of results and evaluation of data. Will supervise 2 research associates and 1 lab technician. Master’s degree in Biotechnology. Please ask to speak with Agnes Chen regarding this posting.