苏州招聘

ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标

1. Provide full support to the Regulator Affairs Manager- to ensure that all aspects of the registration program in China are conducted in accordance with the requirements of the company and the regulators.
2. Provide dedicated support to Franchises and RA representatives WW for the registration of the products manufactured by Johnson & Johnson Medical (Suzhou) Ltd.
3. Facilitate the product registration activities in China by compiling appropriate dossiers, submissions and responses to regulatory bodies. Ensures compliance with regulatory agency regulations and interpretations.
4. Provides solutions to a variety of problems of moderate scope of complexity.
5. Maintain processes for submissions, interim notifications and periodic re-submissions.
6. Maintain information on regulatory requirements and the status of product registrations. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
7. Maintains and archives all regulatory documentation. Conducts searches of existing files for requested information.
8. Provide support and advice to worldwide company colleagues, concerning regulatory requirements in China.
9. Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process in China.

Required Competencies and Skills/所需的能力与技能:

1. Domestic registration experience of Medical device products (Class I, II and III)
2. Excellent planning and organizational skills
3. Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
4. Teamwork and communication and presentation skills – listener, learner and thinker
5. Product awareness and GMP, ISO13485 quality system
6. Continuous and versatile learning ability
7. Thorough and flexible
8. Cross culturally aware
9. Global team player
10. Enthusiastic and committed
11. Written and verbal English skill
12. Possess computer competency in Microsoft office software, data collection and general analysis tools
13. University degree or above