Deskripsi pekerjaan
PT Biomedikal Scientific Indonesia, yang didirikan di Jakarta pada Januari 2020, adalah perusahaan distribusi alat kesehatan yang berfokus pada peralatan diagnostik laboratorium. Sebagai distributor resmi Hologic dan DiaSorin, perusahaan berkomitmen menghadirkan teknologi diagnostik berkualitas tinggi. Posisi Registration Officer bertanggung jawab dalam proses registrasi alat kesehatan (Izin Edar/AKL), penyusunan dokumen dossier, serta memastikan kepatuhan terhadap regulasi pemerintah dan standar CDAKB.
Tanggung jawab: Registering medical devices (Izin Edar/AKL) with the Ministry of Health or other related government institutions; Reviewing, preparing, translating, and compiling dossiers/documents required for medical device registration and additional data requests from Kemenkes; Preparing and compiling product specification data for registration with government agencies and the E-Catalog system; Handling OSS System, E-Report System and Audit CDAKB; Issuing Certificate of Spare Parts (Surat Keterangan Sparepart) to support instrument maintenance; Reviewing product labeling and ensuring all registration documents are valid and compliant with regulation standards; Formulating plans together with the Marketing team based on approved directives; Drafting specifications alongside the Product team for electronic catalog needs and product registration; Preparing monthly summary reports for planned/renewal registrations and submitted products to Kemenkes; Performing other duties assigned by superior.
Kualifikasi: Minimum education of Bachelor’s (S1) in Pharmacy, Biology, Chemistry or related fields; Preferably with at least 1 year of working experience in a similar position / Regulatory Affairs (preferably in medical devices/Alkes distribution); Good English communication skills; Understanding of basic Science, Molecular, and Biochemistry concepts; Excellent service orientation, high integrity, strong performance, teamwork skills, and innovative mindset; Understanding of CDAKB - Internal Audit; Familiar with E-report system and OSS System.
Benefit: Competitive base salary; BPJS Kesehatan and BPJS Ketenagakerjaan; Transportation and travel allowance; Excellent career development opportunities within a fast-growing and dynamic organization; A supportive, collaborative, and transparent work environment that encourages innovation, teamwork, and continuous learning.
Tanggung jawab
- Registering medical devices (Izin Edar/AKL) with the Ministry of Health or other related government institutions
- Reviewing, preparing, translating, and compiling dossiers/documents required for medical device registration and additional data requests from Kemenkes
- Preparing and compiling product specification data for registration with government agencies and the E-Catalog system
- Handling OSS System, E-Report System and Audit CDAKB
- Issuing Certificate of Spare Parts (Surat Keterangan Sparepart) to support instrument maintenance
- Reviewing product labeling and ensuring all registration documents are valid and compliant with regulation standards
- Formulating plans together with the Marketing team based on approved directives
- Drafting specifications alongside the Product team for electronic catalog needs and product registration
- Preparing monthly summary reports for planned/renewal registrations and submitted products to Kemenkes
- Performing other duties assigned by superior
Kualifikasi
- Minimum education of Bachelor’s (S1) in Pharmacy, Biology, Chemistry or related fields
- Preferably with at least 1 year of working experience in a similar position / Regulatory Affairs (preferably in medical devices/Alkes distribution)
- Good English communication skills
- Understanding of basic Science, Molecular, and Biochemistry concepts
- Excellent service orientation, high integrity, strong performance, teamwork skills, and innovative mindset
- Understanding of CDAKB - Internal Audit
- Familiar with E-report system and OSS System
Benefit
- Competitive base salary
- BPJS Kesehatan and BPJS Ketenagakerjaan
- Transportation and travel allowance
- Excellent career development opportunities within a fast-growing and dynamic organization
- A supportive, collaborative, and transparent work environment that encourages innovation, teamwork, and continuous learning
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Pendidikan
- S1
- Gaji
- Competitive base salary