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.
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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
What sets B. Braun apart?
B. Braun is dedicated to protecting and improving global health. Established in the Philippines in 1985, it leverages over 185 years of innovation from its parent company, B. Braun Melsungen AG, which operates in 64+ countries. Initially focused on sutures and disposables, B. Braun Philippines has grown over 39 years to employ more than 800 sales and service professionals.
We now offer advanced dialysis treatments and a broad range of healthcare solutions, including infusion devices, surgical instruments, sutures, regional anaesthesia, haemodialysis machines, disposables, value-added drugs, and clinical nutrition, delivering comprehensive patient care across the country.
What can we offer you?
- Group Term life Insurance
- Medical and Optical Reimbursement
- Maternity assistance
- Training and development programs
- Engage in fun activities and team building events
What’s next?
Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the first interview. We ask you to conduct two interviews, one in person and one remotely. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary!
We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.
To find out more about our commitment to diversity click here
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To find out more about B. Braun Taiwan just click here