Associate Manager - Regulatory Affairs & QA

Associate Manager – Regulatory Affairs & QA You are a vital part of our future. At B. Braun, we protect and improve individual health worldwide. By sharing expertise, innovation, efficiency, and sustainability, you help us grow and contribute to global healthcare together.

Location: Jakarta & Hybrid Working Model

Role Overview As an Associate Manager in Regulatory Affairs & QA, you will organize, monitor, protect, and support our medical device business by implementing regulatory frameworks for product registration (new, renewal, variation), promotion compliance, vigilance, quality assurance, CDAKB, CPAKB, and other related B. Braun medical device products.

Key Responsibilities

Protect and support B. Braun’s business, innovation, and assets by implementing the regulatory framework and acting as regulatory advisor in building and defending B. Braun.

Manage appropriate regulatory submission and pre‑market registration while interacting with health authorities to obtain and maintain product approvals.

Coordinate and prepare regulatory submissions and strategies.

Support product development teams and other development initiatives.

Provide regulatory guidance to departments or development project teams regarding design, development, and evaluation.

Monitor and report the effectiveness and any adverse effects or side effects of medical device products on the market in the general population, hospitals, and research trials.

What You Will Bring to the Team

Minimum a degree in Pharmacy.

Minimum 10 years of working experience in medical device regulatory affairs, CDAKB, and CPAKB.

Fluent in English.

What Sets B. Braun Apart B. Braun Indonesia has over 30 years of experience in the Indonesian market and a new pharmaceutical plant established in 2017. We share knowledge and expertise to protect and improve health in Indonesia and worldwide.

Benefits

Hybrid work system.

Company devices provided.

Education support & personal development.

Medical insurance.

Annual leave.

Regular team building and employee social gatherings.

What’s Next After receiving your application, our Talent Acquisition team will review it carefully. If you stand out, you will be invited to dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout the process, we will keep you informed and inspired with regular updates and feedback. After selection, we will lead you into our seamless onboarding experience.

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