Brilitas Pharmaceuticals

Company Overview:

Brilitas Pharmaceuticals (Vietnam) is a multinational corporation specializing in providing EU Registration Services for medical devices and in-vitro diagnostic medical devices manufactured in Vietnam. Our mission is to ensure compliance with the highest standards of quality and safety, facilitating the global market entry of innovative medical technologies.

Job Description:

As a Regulatory Affairs Specialist focusing on EU Registration Services, you will play a pivotal role in ensuring that our medical devices and in-vitro diagnostic products meet the regulatory requirements for entry into the European market. This position is particularly suitable for individuals with a strong background in Quality Assurance/Quality Control (QA/QC) and familiarity with ISO 13485 standards in medical device manufacturing.

Key Responsibilities:

1. Regulatory Compliance Management:

- Collaborate with cross-functional teams to ensure that products meet EU regulatory standards.

- Oversee the preparation and submission of regulatory documents to relevant authorities.

2. QA/QC Integration:

- Leverage your expertise in QA/QC to integrate regulatory compliance with quality management systems.

- Ensure alignment with ISO 13485 standards and maintain compliance throughout the product lifecycle.

3. EU Market Entry Strategies:

- Provide strategic input on regulatory affairs to facilitate market entry and commercialization in the EU.

4. Documentation and Reporting:

- Prepare and maintain technical files, dossiers, and other necessary documentation for EU submissions.

- Generate reports on regulatory compliance and keep stakeholders informed of progress.

5. Advisory Role:

- Act as a subject matter expert on EU regulations for the organization.

- Offer guidance on regulatory requirements, compliance strategies, and potential risks.