Job Description
Position: Regulatory Affairs Manager
n Job Description:
¡¤ Coordinate and Manage timely Regulatory Submissions between local **** company (or throughout the region) and **** Manufacturers.
¡¤ Work with **** manufacturers to provide strategy and multiple options for meeting regulatory requirements (provide ¡°can do¡± solutions, not ¡°cannot do¡± roadblocks)
¡¤ Personally write and review Regulatory Submissions as needed
¡¤ Organize electronic database (electronic library) of Regulatory Documents and government notifications on GTW (Global Technical Warehouse)
¡¤ Create training documents to improve regulatory skills in Local office (or throughout the region) and at **** manufacturers
¡¤ Train employees to improve regulatory skills in local office or region and at **** manufacturers, where applicable
¡¤ Negotiate with local authorities on behalf of **** objectives
¡¤ Support reimbursement efforts for all submissions where applicable
¡¤ Represent ****as a member of industry organizations
¡¤ Learn the **** Group vision for each regulatory submission and become a trusted leader in the organization
n Qualifications
Degree in science, engineering
n Skills
¡¤ Fluent in English, both spoken and written
¡¤ Experience working for International companies
¡¤ Experience in regulatory for medical device industry
¡¤ Experience in negotiating with regulatory authorities
¡¤ Interpersonal Skills
¡¤ Organizational Skills
¡¤ Familiarity with Windows XP (Word, Excel, Power Point, Outlook Exchange, Lotus Notes)
n Requirements
¡¤ Availability and willingness to travel in country and overseas.
¡¤ Capability to participate in training in USA or other countries.
¡¤ Positive attitude
¡¤ Cooperation with other **** Asia/Pacific staff
¡¤ Strong management ability
¡¤ Strong leadership ability
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¿¬¶ôó:010-2087-1298 / jemoon73@gmail.com
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