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

Info Loker

Perusahaan	PT APT Medical Indonesia
Posisi	Regulatory Affairs
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