Associate Manager Regulatory Affair & QA

B. Braun Melsungen AG; Daerah Khusus Ibukota Jakarta; Hybrid; IDR 200.000.000 - 300.000.000; Full time

Job summary

Perusahaan perubatan terkemuka di Jakarta mencari seorang Associate Manager Regulatory Affair & QA yang berpengalaman. Anda akan bertanggungjawab menguruskan pendaftaran dan pematuhan produk perubatan. Calon ideal mempunyai pengalaman sekurang-kurangnya 10 tahun dalam bidang tersebut dan ijazah dalam Farmasi. Posisi ini menawarkan sistem kerja hibrid dan pelbagai faedah termasuk insurans kesihatan dan sokongan pendidikan.

Benefits

Sistem kerja hibrid

Peranti syarikat disediakan

Sokongan pendidikan & pengembangan peribadi

Canteen di lokasi

Insurans kesihatan

Cuti tahunan

Acara pembinaan pasukan dan sosial

Qualifications

• Sekurang-kurangnya 10 tahun pengalaman dalam politik pengawalan peranti perubatan.
• Kepakaran dalam CDAKB dan CPAKB.

Responsibilities

• Melindungi dan menyokong perniagaan melalui rangka kerja regulatori.
• Menguruskan penyerahan pengawalan yang sesuai dan pendaftaran produk.
• Menyokong pasukan pengembangan produk dengan panduan regulatori.

Skills

Regulatory compliance

Fluent in English

Education

Degree in Pharmacy

Job description

Associate Manager Regulatory Affair & QA Job Description

Anda merupakan bahagian penting daripada masa hadapan kami. Semoga, kami juga sebahagian daripada masa hadapan anda! Di B. Braun, kami melindungi dan menambah baik kesihatan individu di seluruh dunia. Anda menyokong visi ini, membawa kepakaran dan berkongsi innovasi, 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 Perkongsian Kepakaran

Associate Manager Regulatory Affair & QA

Company: PT B. BRAUN MEDICAL INDON

Location: ID-Jakarta (Tempo Scan Tower)

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’s medical devices products.

Your 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 the appropriate regulatory submission and pre-market registration, while also interacting with health authorities to obtain and maintain products approvals
• Coordinate and prepare regulatory submissions and strategies
• Support product development teams and other product development initiatives
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation
• Monitor and report the effectiveness and any adverse effects or side effects of medical devices products on the market in the general population, hospitals, and research trials.

What you will bring to the team:

• A minimum of a degree in Pharmacy
• At least 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 over 30 years of experience in the Indonesian market. In 2017, B. Braun Indonesia established a new pharmaceutical factory, leading to the formation of PT B. Braun Medical Indonesia and PT B. Braun Pharmaceutical Indonesia. We continue to share knowledge and expertise to protect and improve health in Indonesia and worldwide.

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 social gatherings

What’s next?

Our Talent Acquisition team will review your application thoroughly. If selected, you’ll be invited for interviews via phone, video, or in-person. We will keep you updated throughout. If you join us, you will experience seamless onboarding. Join us and be part of something extraordinary!

We value diverse perspectives, backgrounds, and experiences, fostering an inclusive and respectful work environment where everyone can be themselves.

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 learn more about B. Braun Indonesia, just click here.

PT B. BRAUN MEDICAL INDONESIA | Nicky Wu |

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