Lowongan Kerja Jakarta Raya Posisi Regulatory Affairs Specialist di PT APT Medical Indonesia

Info Loker

Perusahaan	PT APT Medical Indonesia
Posisi	Regulatory Affairs Specialist
Tempat	Jakarta Raya
Tingkatan Kerja	Pegawai (non-manajemen & non-supervisor)
Kualifikasi	Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Farmasi, Layanan Kesehatan
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

Main Purpose of the Job

• Provide appropriate regulatory strategy and planning for new product registration and product change registration/record to MoH
• Ensure timely and well organized regulatory activities in Indonesia
• Tender Management/Support and E-Katalog application

Job Description

• Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance in Indonesia
• Advises teams on regulatory strategy and requirements
• Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions
• Creates, reviews and validates marketing and labelling materials while supporting projects and other key regulatory initiatives
• Evaluate the results of new and existing regulation to ensure each protocol runs properly

Qualification

• Bachelor degree in science, pharmacy or relevant major will be preferred
• Minimum 2 years of working experience as Regulatory Affairs in Medical device industry
• Proficient in English both oral and written
• Understanding IDAK, CDAKB, OSS and e-Katalog
• Have knowledge of laws and regulations regarding the distributor of medical instruments
• Familiar with global medical device regulation
• Excellent interpersonal and team skills, ability to work with cross-function and cross-country team
• Highly detailed & organized, analytical & problem-solving skills

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Kesehatan/Medis
• Waktu Proses Lamaran: 29 hari