Regulatory Affairs Specialist

9 hours ago


Thành phố Hồ Chí Minh, Vietnam Beckman Coulter Diagnostics Full time

**Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.**

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The _Regulatory Affairs Specialist _for Beckman Coulter Diagnostics is responsible _for managing all registration activities of all products distributed by Beckman Coulter Vietnam /Channel Partners in Vietnam and Cambodia, ensuring that all regulatory projects are completed within projected timelines. _

This position is part of the _Quality and Regulatory Affairs _located in _HCMC, Vietnam _and will be_ working as _onsite.

You will be a part of the _SEA-North Quality and Regulatory Affairs team _and report to the _Senior Regulatory Affairs Specialist _responsible for Vietnam and Cambodia. If you thrive in a collaborative and fast-paced environment and want to work to build a world-class Commercial organization—read on.

**In this role, you will have the opportunity to**:

- Ensure on-time product registrations (new, re-registration and variations) and handling all regulatory matters with Vietnam MOH.
- Assist and coordinate regulatory support for Vietnam channel partners.
- Manage the registration activities for Cambodia Channel Partner including the analyzing upcoming product variations and determine whether variation registration is required.
- Request/Review/check regulatory documents to ensure completeness and correct to attain right first-time submission.
- Effectively create and update registration record into Regulatory database.
- Other registration administrative support works as assigned by Senior RA Specialist.

**The essential requirements of the job include**:_ (NOTE For Hiring Manager: Please reference the 3-5-7 Model for Job Requirements found _**_here_**_)_**
- Education: Bachelor’s degree in Science/ Pharmacy/ Medical Engineering
- Experience: Minimum 03 years-experience in Regulatory environment for medical devices.

**It would be a plus if you also possess previous experience in**:

- Worked in similar QRA position to in IVD industry.
- Familiar with local product registration procedures and requirements in Vietnam, Cambodia.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.



  • Ho Chi Minh City, Vietnam Page Group Vietnam Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận)The Regulatory Affairs Specialist will own their desk of product compliance and provide knowledge of local regulation to internal and external stakeholders. The position will report directly to regional manager and collaborate with regional team to support customers across Southeast Asia. Technical...


  • Ho Chi Minh City, Vietnam Văn Phòng Đại Diện Nibblen Life Sciences Private Limited Tại Thành Phố Hồ Chí Minh Full time

    **Mô tả công việc**: (Mức lương: 8 - 25 triệu VNĐ) - Prepare Registration dossier for new products, renewal, extension in comply with MOH’s regulations and Regulatory plan - Handle regulatory administrative tasks - Support Marketing & Market access teams in submission and following up related dossiers with MOH - Updated with latest Laws and...


  • Ho Chi Minh City, Vietnam Văn Phòng Đại Diện Nibblen Life Sciences Private Limited Tại Thành Phố Hồ Chí Minh Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) - Prepare Registration dossier for new products, renewal, extension in comply with MOH’s regulations and Regulatory plan - Handle regulatory administrative tasks - Support Marketing & Market access teams in submission and following up related dossiers with MOH - Build and maintain good relationship...


  • Ho Chi Minh City, Vietnam TẬP ĐOÀN Y KHOA HOÀN MỸ Full time

    Quay lại trang tìm kiếm 2 tuần trước **REGULATORY AFFAIRS DIRECTOR**: Ứng tuyển ngay Vị trí TP. HCM Lương Thỏa thuận Công ty Tập đoàn Y khoa Hoàn Mỹ Phòng ban GCEO’s Office Loại hình Full time **JOB SUMMARY**: The Regulatory Affairs Director will work alongside the HMC Group legal and compliance team and reports...


  • Ho Chi Minh City, Vietnam Công Ty TNHH Luxasia Việt Nam Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) To manage registration and compliance matters for global brands according to Vietnam’s regulation. Principal Accountabilities Main responsibilities: - Manage the processes to notify DAV or to obtain regulatory approvals for new / existing products within the identified timeframes - Manage the...


  • Ho Chi Minh City, Vietnam Prudential plc Full time

    Prudential’s purpose is to be partners for every life and protectors for every future. Our purpose encourages everything we do by creating a culture in which diversity is celebrated and inclusion assured, for our people, customers, and partners. We provide a platform for our people to do their best work and make an impact to the business, and we support...


  • Thành phố Hồ Chí Minh, Vietnam Công Ty TNHH An Hải VN Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) Liaise with the brand principals to collect the registration documents, ensure that all products comply with the current enforced regulations in Vietnam & ASEAN. Support the maintenance of regulatory files and updating new databases to ensure prompt and accurate access to company regulatory...


  • Ho Chi Minh City, Vietnam Công Ty Cổ Phần Thương Mại Việt Nữ Full time

    **Mô tả công việc**: (Mức lương: Đến 14 triệu VNĐ) - Products registrations: submit new, renew and follow-up of all registration documents for all products: cosmetics, food supplements, medical devices and drugs. - Be proactive to suggest and find solutions when confronted to regulatory affairs issues - Collaborate with authorities in a smart...


  • Ho Chi Minh City, Vietnam DKSH Full time

    **Location**:Ho Chi Minh, VN, VN**Job Function**:Client and Customer Services**Requisition Number**:143826**Description**: **Job Summary** - Manage and archive PV documents and RA/PV SOPs **General Responsibilities** **Pharmacovigilance** - Assume back-up role in the absence of PV main contact - Receive, follow up Safety reporting case - Prepare Safety...


  • Ho Chi Minh City, Vietnam Công Ty TNHH Qualtech Consulting Corporation Full time

    **Mô tả công việc**: (Mức lương: 4 - 9 triệu VNĐ) **Introduction** Qualtech is an Asia Medical Device Consulting and Clinical Trial (CRO) Company with branch offices in China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Vietnam, Thailand, Korea, USA and Germany. We are looking for a Talented Regulatory Affairs Intern who is...


  • Thành phố Hồ Chí Minh, Vietnam Công ty TNHH Transmedic Healthcare Việt Nam Full time

    **Mô tả công việc**: (Mức lương: Đến 3 triệu VNĐ) - Be responsible for compliance and product registration (medical device, health supplement, cosmetic and medicine). A&P registration and make price disclosure. - Maintain and track the registration status of all marketed products. - Maintain data in information systems or databases,...


  • Thành phố Hồ Chí Minh, Vietnam Công Ty TNHH Maker Sixty Four Full time

    **Duties**: - Oversee and manage all discipline process within the company **Employee Relations** - Keep-mood employees and track their needs daily, weekly and monthly. - Assisting in the onboarding process for new employees, including preparing workstations, coordinating IT setup, and providing necessary resources. - Manage employee feedback on all...

  • Regulatory Affair

    3 weeks ago


    Thành phố Hồ Chí Minh, Vietnam Công Ty TNHH Dược Phẩm New Far East Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) - Check and evaluate the CTD dossier and legal documents for the registration of imported drugs as per current regulation/guideline - Prepare administrative part and coordinate with manufacturer to collect all sufficient dossier for submission. - Check, prepare and submit GMP file for GMP...


  • Ho Chi Minh City, Vietnam Confluence Technologies Inc. Full time

    **Regulatory/Reporting Specialist** **_ HCMC_** **Why Confluence?** Over the past several years we have undergone a great deal of positive change and growth to become the company we are today. Our global footprint now spans multiple countries, giving our employees the opportunity to get exposure to other countries and cultures. And it stands to reason...


  • Ho Chi Minh City, Vietnam Dow Full time

    At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect the communities we live in and the world where we do business. Their diversity is our strength. We’re a community of relentless problem...


  • Ho Chi Minh City, Vietnam Talentnet Full time

    FMCG **RESPONSIBILITIES**: As the Corporate Affairs Manager, you will be responsible for developing and implementing advocacy strategies to enhance company reputation and promote its interests among our stakeholders, working closely with the Line Manager. You will engage with key external stakeholders, including government agencies, industry associations,...


  • Ho Chi Minh City, Vietnam Talentnet Full time

    $2,000 - $3,000 - FMCG **RESPONSIBILITIES**: As the Corporate Affairs Manager, you will be responsible for developing and implementing advocacy strategies to enhance company reputation and promote its interests among our stakeholders, working closely with the Line Manager. You will engage with key external stakeholders, including government agencies,...

  • Regulatory Affair Lead

    4 months ago


    Ho Chi Minh City, Vietnam PERSOLKELLY VIETNAM Full time

    Attractive Salary - Premium Healthcare - International working environment **A. Responsibilities**: Manage new product introduction for general chemicals, biocides, cosmetics and veterinary health products and more: - Provide direction to Marketing, R&D, Supply chain Operations, and Sales to facilitate speed to market and to maintain compliance with...


  • Ho Chi Minh City, Vietnam Tech Data Full time

    The Sr. Regulatory Compliance Specialist is a key position in the Regulatory Compliance organization. This position supports import, export and licensing functions and drives the daily compliance activities required under the company's trade compliance policy. Export Functions: The Sr. Regulatory Compliance Specialist is responsible for resolving potential...


  • Thành phố Hồ Chí Minh, Vietnam Kuehne+Nagel Full time

    You will be joining our Operational Care Team to add your expertise + skills to the delivery of Operational Excellence. ** Your Role**: You will be enabling transport activities by executing bookings, entering orders while liaising with our Customer Care Specialists to ensure all requirements are met (in a timely and efficient manner). As always, these...