南京招聘

Key Accountabilities/ Responsibilities:

1. Implement registration action plan, technical support to line manager for preparing and filing registration dossier on schedule.

2. Prepare related testing materials for type testing, contact with testing center for agreement, protocol, implement, report, sample delivery, payment, invoice and other logistics, follow up test process to ensure timely complete.

3. Creation, proofreading and editing of labeling materials including cartons, operation manuals, package inserts and meter back labels. Follow up with global packaging team for English baseline and Chinese artwork of all product lines to be sold in China in line with regulatory requirements.

4. Be Responsible for assisting day-to-day RA efforts, etc. collection update information of registration regulation, guidelines, standard and other regulatory policies.

5. Make expense application for all RA activities. Communicate with vendors and host finance, tracking the whole process of purchase and payment to ensure that the services are provided on time.

6. Collect information on competitive products to be approval and provide related supports to Business and other functional groups as required.


Qualifications/Requirements (Education/Experience/Competencies):

1. 2 + years working experience in medical device or pharmaceutical industry.
2. Good knowledge and experience in science and technology, clinical diagnostics, or biochemistry, preferably with experience in product registration and field development.
3. Bachelor or above degree
4. Good communication skills.
5. Good cooperation and teamwork.
6. Fluent English skill (write, read, comprehend and oral).
7. Strong computer proficient including MS Office skills (Word, Excel, Power Point)
8. Be patient, be careful on paper work
9. Positive working attitude and a good team player
10. Strong process management, organization and documentation skills

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