Regulatory Affairs Specialist

1 week ago


Jakarta, Indonesia Swakarya Insan Mandiri Career Center Full time

**Peran & Tanggung Jawab**:

- Bertanggung jawab atas proses registrasi AKL/NIE untuk produk Samsung Healthcare di Kementerian Kesehatan.
- Memastikan kepatuhan terhadap regulasi yang ditetapkan oleh Kementerian Kesehatan.
- Memantau dan memahami peraturan yang relevan sesuai dengan bisnis kesehatan.
- Menganalisis dampak perubahan regulasi terhadap perusahaan.
- Mengembangkan dan mengimplementasikan program untuk memastikan kepatuhan terhadap regulasi dari Kementerian Kesehatan.
- Menyiapkan dan memelihara dokumen terkait kepatuhan regulasi.
- Berkolaborasi dengan departemen lain di perusahaan seperti produksi, pemasaran, dan hukum untuk memastikan semua pihak mematuhi peraturan.
- Melakukan riset dan analisis terhadap tren regulasi yang sedang berkembang serta potensi dampaknya terhadap perusahaan.

**Persyaratan**:

- Minimal lulusan Diploma (D3) atau lebih tinggi, jurusan Manajemen, Administrasi Publik, atau Hukum Bisnis.
- Memiliki pengalaman kerja lebih dari 5 tahun di industri kesehatan.
- Memiliki kemampuan berbicara dan menulis bahasa Inggris tingkat menengah.
- Bersedia melakukan perjalanan dinas domestik dan internasional. Berdomisili di Jakarta.

Jenis Pekerjaan: Kontrak
Panjang kontrak: 3 bulan

Pertanyaan Lamaran:

- Berapakah usia anda saat ini?
- Dimanakah domisili anda saat ini?

Pendidikan:

- D1-D4 (Diwajibkan)

Pengalaman:

- Regulatory Affairs Specialist - Medical Devices: 5 tahun (Diwajibkan)



  • Jakarta, Indonesia Boston Scientific Corporation Full time

    **Regulatory Affairs Specialist**: - Remote Eligible: Hybrid- Onsite Location(s): Jakarta, IDWe are seeking a Regulatory Affairs Specialist for our Indonesia Team. He/she ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. He/she Interacts with...


  • Jakarta, Indonesia Johnson & Johnson Full time

    Johnson & Johnson is recruiting a Regulatory Affairs Specialist based in Indonesia The Regulatory Affairs Specialist, Medical Device, Indonesia, is a member of the local Regulatory Affairs department, responsible for actively contributing to the regulatory compliance of medical devices under their responsibility. The position is responsible for providing...


  • Jakarta, Indonesia DKSH Full time

    **Location**:Jakarta, ID, ID**Job Function**:Regulatory Services**Requisition Number**:137312**Description**: **Job Summary** Manage the local implementation of the company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and...


  • Jakarta Metropolitan Area, Indonesia Glad2Glow Full time

    The Senior Regulatory Affairs is responsible for managing the end-to-end registration process for assigned brands at Glad2Glow. This includes ensuring all product documents, ingredients, and labels meet BPOM regulations, coordinating with the regional team, and overseeing testing and compliance efforts. You will lead a small brand-focused team, monitor...


  • Jakarta, Indonesia International Flavors & Fragrances Full time

    Are you passionate about Regulatory Affairs? Would you love to work for a global organization that is doing more good for people and planet? Joining science and creativity, we are an international collective of thinkers who partner with customers to bring scents, tastes, experiences, ingredients and solutions for products the world craves. We have an...


  • Jakarta, Indonesia PT. Prima Bersama Berkat Full time

    Manage licensing and permitting processes for company establishment and operations. - Ensure compliance with Indonesian regulations and laws, including environmental and trade regulations. - Conduct research and analysis on government policies, incentives, and regulations affecting the company. - Provide legal advice and support on manufacturing management,...


  • Jakarta, Indonesia Hyphens Pharma International Limited Full time

    COMPANY DESCRIPTION **Listed on the Catalist board of the Singapore Exchange (SGX), Hyphens Group has a direct presence in Singapore (HQ), Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering additional jurisdictions like Hong Kong, Myanmar, Brunei, Cambodia, Oman, Bangladesh, South Korea and...


  • Jakarta, Indonesia Merck Group Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...


  • Jakarta, Indonesia Merck Group Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...


  • Jakarta, Indonesia LUXASIA Full time

    LUXASIA is the leading beauty omnichannel distribution platform of Asia Pacific that has successfully enabled brand growth for more than 120 luxury beauty brands. Our integrated brand-building capabilities include luxury retail, online commerce, consumer marketing, and supply chain management. Since 1986, the company has partnered the world’s finest...