Are you passionate about Executive - Quality Management & Regulatory Affairs and its processes? If so, this opportunity could be for you! Join us at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! 

As a Executive - Quality Management & Regulatory Affairs at B. Braun you plays a vital role in post‑marketing surveillance, quality management system implementation, GDP compliance, audits, recalls, and regulatory liaison to ensure full compliance with corporate and local regulations. Additionally, manages SOPs, vendor assessments, documentation control, training, reporting, and coordination with global quality teams and authorities to maintain regulatory and quality standards.

Your key responsibilities: 

•  Lead Quality Management activities, including post‑marketing surveillance (ADR, complaints), GDP compliance, SOP management, audits, CAPA follow‑up, recalls/FSCA, document control, and quality system maintenance.
• Ensure regulatory and quality compliance with corporate standards and Taiwan regulations by liaising with local authorities, monitoring regulatory updates, and implementing required procedural changes.
• Plan and execute Regulatory Affairs strategies to support timely product registration, amendments, renewals, import/export permits, and licensing across the product life cycle.
• Serve as a trusted regulatory and quality business partner, providing strategic regulatory input, managing submissions, assessing product changes (e.g. labeling updates), and supporting new product launches and portfolio management.
• Manage external stakeholders and third parties, including vendor GDP assessments, 3PL/4PL audits, dossier maintenance, and collaboration with global QA/RA teams.
• Drive training, reporting, and continuous improvement, delivering QA/RA training, providing regular compliance and status reports, supporting market access and government affairs, and proactively improving processes to optimize efficiency and compliance.

 What you will bring to the team: 

• University degree or above in business, marketing, medical science, medicine, nursing, or a related field
• 1–3 years of experience in quality management and/or regulatory affairs, preferably in the medical device industry
• Strong ability to work independently, manage multiple tasks, and operate effectively in a matrix organization
• Excellent teamwork and interpersonal skills, with the ability to collaborate cross‑functionally
• Proficient in MS Office with excellent spoken and written English skills