Regulatory Affairs Assistant Manager

PHILIPS VIETNAM
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Mô tả công việc


Summary of Position with General Responsibilities:
This position is responsible for supporting Q&R tasks and participate in key Q&R projects locally with primary focus on product registration/renewal/re-registration, quality support as well as providing department administrative support where needed.
Essential Job Functions:
•Performs the coordination and preparation of document packages (CSDT) for the pre-market regulatory submissions locally and if required, regionally.
•Prepares and submits Field Corrective Action reports and adverse event reports to the local competent authority, if required, including any additional communications to local competent authority.
•Good Communication skills, including maintaining good working relationships with local competent authorities from various different departments or agencies.
•Reviews and obtain approval from line manager on local labeling, assist with the right processes to take place locally.
•Provides supports for local tasks including preparation of first time registration, renewal and re-registration.
•Support the local/regional Quality Management System(s) (policies, procedures, work instructions), with revisions and implementations of new regional policies and processes.
•Assist and participate in local/regional internal audits as well as observing and assisting in the preparation for L1 & L2 audits
•Assist and drive CAPA process locally.
•Maintain ASEAN Quality Management System (policies, procedures, work instructions)
•Assist quality initiative projects with investigation and data collection.
•Assist in driving the completion of Training Management System locally.
•Review and process customer feedback and complaints between market and BIU.
•Assists the in administrative duties related Q&R (i.e. maintenance of registration database, document control, update of licenses on network drive/share point site, webs based application etc.).
•Assist project assigned by line manager.

Yêu cầu công việc


Basic Qualifications:
•Bachelors Degree with minimum 5 years of experience strongly in Quality and/or Regulatory Affairs (especially in Medical Devices)
•Proficiency in the use of Microsoft Access and Excel is an advantage.
•Strong interpersonal skills in the areas of verbal and written communication, telephone courtesy and professionalism.
•Strong organizational skills and take initiative.
•Attention to detail and the ability to maintain confidentiality of product registration documents.
•Ability to prioritize and handle several projects concurrently.
•Must be self-motivated and have ability to take ownership of her/his responsibilities.
•Must be a team player and capable of working with minimal supervision.
•Must be able to set goals and accomplish them within set time schedule and budget.
Additional Desirable Qualifications Skills and Knowledge:
•Must have command of the English language.
•Ability to solve practical problems and deal with a variety of situations where limited direction has been given. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

Quyền lợi





Chance to promote long term career





Competitive health benefits





Flexible work schedule


Cập nhật gần nhất lúc: 2020-03-31 11:30:01

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PHILIPS VIETNAM

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Thông tin chung

Ngành nghề
Y tế/Chăm sóc sức khỏe, QA/QC, Trình dược viên
Cấp bậc
Nhân Viên
Kinh nghiệm yêu cầu
Đang cập nhật
Trình độ yêu cầu
Đang cập nhật
Số lượng cần tuyển
Đang Cập Nhật
Hình thức làm việc
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Giới tính
Đang cập nhật
Hạn nộp hồ sơ
25/03/2020
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