Develop strategies for new IVD applications and reimbursement coverage.
•Conduct IVD submission applications, reimbursement application and necessary in-house procedures for new products.
•Conduct IVD application and reimbursement coverage plans with MKTG, R/D and department heads for products of the division in charge.
•Evaluate product change communications and implement responses. Perform necessary pharmaceutical procedures if applicable.
•Conduct timely reviews of advertisements, customer letters, etc.
•Train members of the Regulatory Affairs Department and other project team members on IVD applications, regulations, laws and regulations.
•Participate in industry association activities to maintain the dominant compliance position and contribute to industry development.
•Report progress to senior management and take leadership in application and compliance strategies.
•Formulate solutions to pharmaceutical issues with government agencies and other companies, make recommendations and negotiate directly if needed.
•Balance pharmaceutical regulations with business, consider compliance measures and make recommendations. Perform other duties as directed.
TOEIC: 600 or more. Requires teleconference with overseas manufacturing plants.

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