Lowongan Kerja Serang Posisi Regulatory Executive – Medical Device di Flexicare (Group) Limited

Info Loker

Perusahaan	Flexicare (Group) Limited
Posisi	Regulatory Executive - Medical Device
Tempat	Serang
Tingkatan Kerja	Pegawai (non-manajemen & non-supervisor)
Kualifikasi	D3 (Diploma), D4 (Diploma), Diploma Pascasarjana, Gelar Professional, Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Pemasaran/Pengembangan Bisnis, Penjualan / Pemasaran
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

Job Description

• Keeping up-to-date with the Company’s product range. Supporting submissions of registrations, Free Sale Certificate applications, CPAKB licenses, and renewals to strict deadlines ensuring the product certification matches product code/scope.
• Proactively track all registration, maintain registration records, and initiate appropriate renewal activity to ensure that current registrations do not expire and jeopardize sales within Indonesia.
• Keeping abreast of Medical Device Regulation Indonesia and providing guidance to product development teams regarding data and information required to prepare such registrations.
• Support regulatory inspections by local Regulatory Agencies/ Notified Bodies when required.
• Support in confirming labelling and packaging requirements, applicable to Indonesia.
• Coordinate with distributor/ file notification to inform regulatory authorities of Indonesia regarding changes in registered products.
• As and when requested carry out other regulatory/ quality tasks delegated by the manager or senior officers of Flexicare Indonesia.
• Support information request for tender in Indonesia

Requirement

• Minimum 1 – 2 years of work experience in Regulatory Affairs for medical device products.
• Possess at least a Bachelor’s Degree in Science from an accredited university.
• Excellent verbal and written communication skills with strong English language proficiency.
• Strong computer skills.
• Exceptional ability to work independently with minimal supervision, effectively organize, prioritize, and manage multiple projects.
• Positive attitude, strong attention to detail, and ability to solve problems independently.
• Comprehensive understanding of regulatory activities and how they impact other products and/or processes.
• Knowledge of quality management systems, technical file compilation, and Indonesia medical device regulatory requirement

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Kesehatan/Medis
• No. Registrasi: 9109193
• Ukuran Perusahaan: 1001 - 2000 pekerja
• Waktu Proses Lamaran: 23 hari
• Tunjangan dan Lain-lain: Waktu regular, Senin - Jumat, Bisnis (contoh: Kemeja), will be advised during the interview
• Lokasi: Cikande