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 an
Executive - Quality Management & Regulatory Affairs at B. Braun you plays a vital role in postmarketing 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:
- Ensure postmarketing surveillance (adverse events, complaints, ADR), GDP compliance, SOP development and control, quality system implementation, documentation management, training delivery, and regular quality reporting in line with corporate and Taiwan local regulations.
- Conduct internal and external audits (4PLs, dealers, vendors/suppliers), perform GDP evaluations and vendor assessments for outsourced services, drive and monitor CAPA completion, and support recall / FSCA activities as required.
- Liaise with global quality teams, dealers, service providers, and government authorities; monitor regulatory and industry updates, assess impact, implement procedural updates, and ensure timely internal and external communication.
- Plan, lead, and execute regulatory strategies to enable timely product introductions in Taiwan; provide valueadded regulatory guidance and solutions to commercial and crossfunctional teams across the full product lifecycle (pre to postmarket), including strategic submission planning and decisionmaking.
- Monitor and interpret applicable laws and regulatory changes, assess business impact, and provide Taiwanspecific regulatory opinions; act as the authorized regulatory liaison with government authorities and regulatory agencies, ensuring timely communication, data provision, and compliance alignment with corporate objectives.
- Provide strategic regulatory guidance to commercial and crossfunctional teams, ensuring compliance from pre to postmarket.
- Act as the primary regulatory liaison with health authorities, managing licenses, permits, and regulatory intelligence.
What you will bring to the team:
- University degree or above in business, marketing, medical science, medicine, nursing, or a related field
- 13 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 crossfunctionally
- Proficient in MS Office with excellent spoken and written English skills
What sets B. Braun apart
Since its establishment over 35 years ago, B. Braun Taiwan has been deeply rooted in Taiwan. To further fulfill the commitment of Sharing Expertise, B. Braun's Aesculap Academy has also chosen Taiwan for its interdisciplinary medical exchanges and dialogues, aiming to contribute more significantly to surgical education and medical training in the Asia-Pacific region. With that and more than 55 employees, we are dedicated to protecting and improving the health of people in Taiwan through medical, surgical, and pharmaceutical products and services.
What can we offer you
- Annual Bonus and incentive scheme
- Training and development, investing in your future
- Annual Leave and a day off to celebrate B. Braun Taiwan birthday
- Recognition awards
- Option to work from home
- Open office with standup desks
- Unlimited fruits, coffee, milk and snacks
- Group Insurance Program
- Medical checkup
- Events and celebrations to mark special occasions like festival events, annual kick-off event, year-end celebration, spring gathering
- Team building trips and social clubs
What's next
Upon receiving your application, our dedicated Talent Acquisition team will meticulously review your application. If you stand out, you'll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. 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
