Associate Manager Regulatory Affair & QA

B. Braun Melsungen AG; Jakarta Utara; Hybrid; IDR 200.000.000 - 300.000.000; Full time

Job summary

Perusahaan alat kesehatan terkemuka di Jakarta mencari Associate Manager Regulatory Affair & QA. Anda akan memainkan peran penting dalam mengatur, memantau, dan mendukung bisnis alat kesehatan. Diperlukan gelar dalam Farmasi dan minimal 10 tahun pengalaman. Kami menawarkan sistem kerja hybrid dan dukungan pendidikan serta pengembangan personal.

Benefits

Sistem kerja hybrid

Dukungan pendidikan dan pengembangan pribadi

Asuransi kesehatan

Cuti tahunan

Makan siang onsite

Acara team building

Qualifications

• Minimal 10 tahun pengalaman kerja di bidang pengaturan alat kesehatan dan CPAKB.
• Kemampuan berbahasa Inggris yang baik.

Responsibilities

• Melindungi dan mendukung bisnis B. Braun dengan menerapkan kerangka regulasi.
• Mengelola pengajuan regulasi dan pendaftaran produk pra-pasar.
• Koordinasi dan persiapkan strategi pengajuan regulasi.

Skills

Kepatuhan regulasi

Komunikasi yang baik

Analisis

Education

Gelar dalam Farmasi

Job description

Overview

Associate Manager Regulatory Affair & QA. Anda merupakan bahagian penting daripada masa hadapan kami. Di B. Braun, kami melindungi dan menambah baik kesihatan individu di seluruh dunia. Anda menyokong visi ini, membawa kepakaran dan berkongsi inovasi, kecekapan dan kemampanan sebagai nilai. Itulah sebabnya kami ingin terus mengembangkan syarikat kami dengan anda. Juga demi masa hadapan anda, kami membuat sumbangan bersama kepada penjagaan kesihatan di seluruh dunia, dengan kejujuran, ketelusan dan penghargaan. Itulah Perkongsaran Kepakaran.

Company: PT B. BRAUN MEDICAL INDONESIA. Job Posting Location: Jakarta, Jakarta Raya, Indonesia. Functional Area: Regulatory Affairs. Working Model: Hybrid. Requisition ID: 3596.

Are you passionate about regulatory compliance? If so, this opportunity could be for you! Join us at B. Braun Indonesia, 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 Associate Manager Regulatory Affair & QA at B. Braun you will play a vital role in organizing, monitoring, protecting and supporting the Medical Devices business by implementing the regulatory framework in the context of products registration (new registration, renewal, variation), promotion compliance, vigilance, quality assurance, CDAKB, CPAKB and other related B. Braun medical devices products.

Responsibilities

• Protect and support B. Braun’s business, innovation, and assets by implementing the regulatory framework and act as regulatory advisor in building and defending B. Braun
• Manage the appropriate regulatory submission and pre-market registration, while also interacting with health authorities to obtain and maintain products approvals
• Coordinate and prepare regulatory submission strategies
• Support product development teams and other product development initiatives
• Provide regulatory guidance to department or development project teams regarding design, development, evaluation
• Monitor and report the effectiveness and any adverse effects or side effects of medical devices 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 Devices regulatory affairs, CDAKB and CPAKB
• Fluent in English

What sets B. Braun apart?

B. Braun in Indonesia began in the 1980s through a local distributor, bringing with it over 30 years of experience in the Indonesian market. Committed to staying at the forefront, B. Braun Indonesia established a new pharmaceutical factory in 2017. This expansion led to the formation of two legal entities: PT B. Braun Medical Indonesia and PT B. Braun Pharmaceutical Indonesia. Today, we’re proud to still be sharing knowledge and expertise with the community to protect and improve the health of people in Indonesia and around the world.

What can we offer you?

• Hybrid work system
• Company devices provided
• Education support & personal development
• Onsite canteen (Plant/Factory based)
• Medical Insurance
• Annual Leave
• Regular team building and employee social gatherings

What’s next?

Our Talent Acquisition team will review your application. If you stand out, you’ll be invited to interview via phone, video, or in-person. We will keep you informed with updates and feedback throughout the process. If you join us, you’ll experience our onboarding process.

We value diverse perspectives, thoughts, experiences and backgrounds, and strive for an inclusive, respectful and equal working environment. To learn more about our commitment to diversity, click here.

Check us out on Social Media!

B. Braun Group LinkedIn

B. Braun Group YouTube

To find out more about B. Braun Indonesia, click here

PT B. BRAUN MEDICAL INDONES|Nicky Wu|

Copyright  B. Braun SE