Mô tả công việc
Purpose of Function
- Support & perform regulatory tasks as assigned by RA Manager in full compliance with local and international regulations.
- 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.
- Desirable: Minimum 1 years of working experience.
- 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:
- Proactive, agile
- Patient, hardworking
- Organizational, job arrangements skills
- Good comprehension & writing skill of English
- Expertise in MS Office (Word, Excel, Powerpoint)
- Problem solving skill
- Has positive mindset
- Strong communication skills
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
Phúc lợi công việc
- Bảo hiểm theo quy định
- Du Lịch
- Phụ cấp
- Xe đưa đón
- Du lịch nước ngoài
- Đồng phục
- Chăm sóc sức khỏe
- Đào tạo
- Tăng lương
- Công tác phí
- Phụ cấp thâm niên
- Chế độ nghỉ phép
Cách thức ứng tuyển
Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút Nộp đơn dưới đây