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Chuyên viên RA

Công ty Cổ phần Nhà máy Trang Thiết bị Y tế USM Healthcare (USM Healthcare Medical Devices JSC)

Mức lương: 8 - 10 triệu Kinh nghiệm: 1 năm Nơi làm việc: Tp Hồ Chí Minh

Trình độ: Đại học Đã hết hạn

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Nộp đơn Lưu việc làm

Mô tả công việc

Purpose of Function

Support & perform regulatory tasks as assigned by RA Manager in full compliance with local and international regulations.

Job Responsibility

Preparation of all materials / regulatory documentation needed for submission, license renewal and annual registration according to regulatory requirements of various regions or to commercial partners as requested.
Liaise with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review as requested.
Maintain regulatory files / database in good chronological order.
Maintain system for tracking changes in documents submitted to agencies or partners.
Registration of intellectual property, product trademark, business registration.
Recommend changes, review and approval for manufacturing procedures, labeling / advertising / marketing materials and clinical protocol and process/test methods changes for regulatory requirements and laws compliance.
Provide the regulatory reviews of customer complaints and define the regulatory reportability.
Perform coordination in participating in activities such as audits, regulatory agency inspections, or customer complaint handling.
Actively participate in research of regulatory issues and dissemination regulatory information to relevent departments.
Participate in developing standard operating procedures of Regulatory Affairs department.
Protect operations by keeping information confidential.
Perform other tasks and assignments which to be assigned by RA manager.

Yêu cầu công việc

Education: Bachelor’s degree in science or engineering required, vocational training or comparable business experience, medical/technical/law background prefered but not complusory.
Related Experience:

Desirable: Minimum 1 years of working experience.
Preferable:
- Knowledge of local and international medical device industry.
- Experience in registration, or working with authorities, or QA (ISO 9001 or ISO 13485 or GMP preferred)

Skills, Special Competencies, or Certifications:

Desirable:
- Proactive, agile
- Detail-orientated
- Patient, hardworking
- Organizational, job arrangements skills
- Good comprehension & writing skill of English
- Expertise in MS Office (Word, Excel, Powerpoint)
Preferable:
- Problem solving skill
- Has positive mindset
- Strong communication skills

General Requirements:
All employees are expected to:

Act as an ambassador of and in accordance with the company’s Guiding Principles.
Adhere to the company’s Principles of Business and Conduct.
Demonstrate good judgment, and respect the confidentiality of company and personnel information.
Deal professionally and courteously with all internal and/or external contacts.
Seek guidance and direction as necessary in the performance of duties