Việc làm DƯỢC PHẨM HELIOS
Cập nhật 22/11/2024 19:38
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DƯỢC PHẨM HELIOS
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Regulatory Affairs Specialist (Medical Devices)
DƯỢC PHẨM HELIOS
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Thông tin cơ bản
Mức lương:
Thỏa thuận
Chức vụ:
Nhân viên
Ngày đăng tuyển:
Đang cập nhật
Hạn nộp hồ sơ:
19/01/2025
Hình thức:
Toàn thời gian
Kinh nghiệm:
Không yêu cầu
Số lượng:
1
Giới tính:
Không yêu cầu
Nghề nghiệp
Ngành
Địa điểm làm việc
- Hà Nội
Mô tả công việc
Job Main Purpose:
In country Regulatory Affairs to support Bayer Radiology Vietnam business, focused on medical devices.
YOUR ROLE & RESPONSIBILITIES:
• With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for Vietnam registrations for Bayer Radiology medical devices.
• Provide regulatory responses to local health authorities as required in a timely, proactive, systematic, accurate manner, to ensure timely approval new licenses and proper maintenance for existing licenses.
• Provide device regulatory assessments (e.g. product development, life-cycle engineering changes, etc.) for Vietnam as per required timelines to the Global Regulatory Affairs teams.
• Review the labelling materials to ensure the compliance to local labelling requirements. Drive global, regional and local stakeholders for the labelling compliance to Vietnam regulatory requirements.
• Monitor and communicate the new or updated regulations from Vietnam, as well as supporting the impact assessment and implementation strategy as needed; and ensure that the device regulatory requirements of Vietnam are kept up to date in database systems.
• Develop and maintain tracking of regulatory activities, including submission prioritization, submission status tracking and submission dossier archiving.
• Support Regulatory device internal processes/SOP/KPI development and roll-out related to Vietnam regulatory activities.
• Support Commercial, Supply Chain, Order to Cash, Legal, Quality and/or Services by providing requested information and advice from Vietnam regulatory standpoint.
• Work in close collaboration, ensuring prioritization, alignment and effective communication with APAC Device Regulatory Head, Vietnam RAD Commercial and Global Regulatory Affairs teams.
• Perform other appropriate duties as assigned by management to support the regional/local radiology business.
In country Regulatory Affairs to support Bayer Radiology Vietnam business, focused on medical devices.
YOUR ROLE & RESPONSIBILITIES:
• With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for Vietnam registrations for Bayer Radiology medical devices.
• Provide regulatory responses to local health authorities as required in a timely, proactive, systematic, accurate manner, to ensure timely approval new licenses and proper maintenance for existing licenses.
• Provide device regulatory assessments (e.g. product development, life-cycle engineering changes, etc.) for Vietnam as per required timelines to the Global Regulatory Affairs teams.
• Review the labelling materials to ensure the compliance to local labelling requirements. Drive global, regional and local stakeholders for the labelling compliance to Vietnam regulatory requirements.
• Monitor and communicate the new or updated regulations from Vietnam, as well as supporting the impact assessment and implementation strategy as needed; and ensure that the device regulatory requirements of Vietnam are kept up to date in database systems.
• Develop and maintain tracking of regulatory activities, including submission prioritization, submission status tracking and submission dossier archiving.
• Support Regulatory device internal processes/SOP/KPI development and roll-out related to Vietnam regulatory activities.
• Support Commercial, Supply Chain, Order to Cash, Legal, Quality and/or Services by providing requested information and advice from Vietnam regulatory standpoint.
• Work in close collaboration, ensuring prioritization, alignment and effective communication with APAC Device Regulatory Head, Vietnam RAD Commercial and Global Regulatory Affairs teams.
• Perform other appropriate duties as assigned by management to support the regional/local radiology business.
Yêu cầu công việc
• MS or BS degree in Engineering, Pharmaceutical, Chemistry or Biological Sciences.
• At least 3 years of proven Vietnam regulatory experience in pharmaceutical or medical device industry, including hands on Vietnam registration experience and direct working experience with IMDA and other regulatory authorities as required for medical devices.
• Familiar with local regulations and regulatory assessment of device design.
• Ability to multitask and focus on multiple issues at one time, prioritize direct diverse activities in a changing environment often under time pressure in a highly regulated environment.
• Proven ability to communicate effectively in English both verbally and in writing.
• Skill and determination to reach successful outcomes in negotiations with both internal cross-functional and external parties.
• Detail oriented and well-organized.
• Excellent interpersonal skills, motivated to work independently as well as with cross-functional teams in line with our company LIFE values and to effectively support RAD businesses.
• At least 3 years of proven Vietnam regulatory experience in pharmaceutical or medical device industry, including hands on Vietnam registration experience and direct working experience with IMDA and other regulatory authorities as required for medical devices.
• Familiar with local regulations and regulatory assessment of device design.
• Ability to multitask and focus on multiple issues at one time, prioritize direct diverse activities in a changing environment often under time pressure in a highly regulated environment.
• Proven ability to communicate effectively in English both verbally and in writing.
• Skill and determination to reach successful outcomes in negotiations with both internal cross-functional and external parties.
• Detail oriented and well-organized.
• Excellent interpersonal skills, motivated to work independently as well as with cross-functional teams in line with our company LIFE values and to effectively support RAD businesses.
Quyền lợi được hưởng
Thưởng
A good Bonus structure
A good Bonus structure
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DƯỢC PHẨM HELIOS
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Quy mô:
25 - 100 nhân viên
Địa điểm:
Văn phòng B.6.02, Tòa tháp B, Tầng 6, Tòa nhà Millennium, số 132 Bến Vân Đồn, Phường 06, Quận 4, Thành phố Hồ Chí Minh, Việt Nam
Công ty TNHH Dược phẩm Helios được thành lập từ năm 2016. Helios định hướng xây dựng doanh nghiệp kinh doanh hiệu quả theo chuẩn mực quốc tế, công ty lựa chọn lĩnh vực hoạt động bao gồm: nhập khẩu, phân phối dược phẩm, mỹ phẩm, thực phẩm chức năng, hoạt chất và thiết bị y tế; dịch vụ tư vấn, xúc tiến thương mại và đầu tư dược phẩm. Lựa chọn các thương hiệu uy tín hàng đầu trên thế giới để mang đến tiếp cận gần hơn phục vụ người Việt Helios là đối tác chiến lược của hơn 50 công ty và phân phối chính hãng nhiều nhãn hàng tại Việt Nam: Velit Biopharma S.R.L (Ý), Alifarm S.A (Tây Ban Nha), Erbozeta S.p.a. (Ireland), UST MFG LLC (Mỹ), Genoscope Sp.z.o.o Sp.k (Ba Lan),... Helios Pharma phân phối sản phẩm trên toàn quốc phủ khắp các tỉnh thành tại hơn 3000 đơn vị uy tín như: Guardian, Sammishop, Pharbaco, Hasaki, Watsons,... Công ty mong muốn trở thành đơn vị được tin tưởng và ưu tiên lựa chọn hàng đầu của khách hàng trong tìm kiếm giải pháp chăm sóc sức khỏe và sắc đẹp.
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