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Officer - Regulatory Affairs
1 month ago
**Job Description**:
You’re an important part of our future. Hopefully, we're also a part of your future At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
- Officer - Regulatory Affairs**Company**:B.Braun Vietnam Co. Ltd.**Job Posting Location**:VN-Hanoi (170 La Thanh Street)**Functional Area**:Regulatory Affairs**Working Model**:Onsite**Req Id**:1122You’re an important part of our future. Hopefully, we're also a part of yours At B. Braun, we protect and improve the health of people worldwide. This is also our vision for sales. Because you recognize potential, hold constructive discussions and are familiar with people and figures, we would like to strengthen our business with you in the long term. In doing so, we promote entrepreneurial spirit, courage, fairness and openness. That’s how we build long-term relationships. That's Sharing Expertise.
B. Braun Vietnam, a subsidiary of B. Braun Melsungen AG Group - one of the world's leading manufacturers of medical devices and pharmaceutical products and services - now operates one of the largest medical complex in Vietnam and has become a prestigious trademark in Vietnam healthcare market. With more than 1,400 employees nationwide, we develop high quality “made in Vietnam” products, especially our infusion solutions, dialysis solutions and plastic medical instruments have widely been used and appreciated in international and domestic markets. Every service provided by B. Braun Vietnam incorporates the entirety of our knowledge and skills, the company's deep understanding of users' needs and extensive expertise.
Our mission is to PROTECT and IMPROVE the health of people around the world. Let’s become a part of the B. Braun family and share your expertise.
Purpose: This position is for registration and other relevant regulatory activities of AC, IC products (medical device and biocide)
Task and responsibility:
1. Update regulation/ internal process of local HA regarding registration activities
1.1) Cooperate with local marketing to get confirmation on registration needs and request required documents for registration
1.2) Assess dispatched documents, and prepare dossiers for submission
1.3) Submission of the registration dossier, follow up and submit supplement dossier if any to get approval
1.4) Request, prepare, submit, and follow up variation dossiers as change management
2. Update regulation/ internal process of local HA regarding registration activities
2.1) Understand clearly all the current regulations regarding product registration including medical devices and biocides, and update and implement new regulations if any
2.2) Understand all internal processes of local HA (IMDA, VIHEMA) regarding evaluation activities of registration. update and adapt timely
2.3) Update and share with the team and relevant department for implementation
3. Cross-function support including tender support and collaboration with SCM for the importation of registered products
3.1) Provide and order required documents as per LSM request for tender
3.2) Coordinate with LSM, and SCM for the importation of registered products, and provide legal or technical documents to them for their process.
4. AW development
4.1) Do artwork development after getting approval for product registration for production
4.2) Do keep informing SCM of the progress of the AW development implementation timeline for placing orders and any changes if any
**Requirements**:
- Pharmacist or Chemical bachelor, at least 2 years of RA experience (medical device), working in MNC or RA experience of pharmaceutical product is a plus
- Having experience & good knowledge in registration activities
- Working experiences in Pharmaceutical/Medical companies are preferable
- Good relationship with the authorities related to registration task is preferable
- Good knowledge and understanding of concerned legal requirement related to product registration for medicinal, medical devices, supplement and infection control products as well as company operational registration
- Good at English both verbal and written.
- Strong verbal and interpersonal skills
- Customer-service oriented
- Self-motivated, requires little direction
- Careful, honest, high sense of responsibility
- Able to work on multiple priorities simultaneously
- Able to follow directions and pay attention to details and deadlines
- Computer literacy, proficient in Microsoft Office Software
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you
