Lowongan Kerja Jakarta Timur Posisi Regulatory Affairs Specialist – Indonesia di ANDAMAN MEDICAL PHILIPPINES CORPORATION

Info Loker

Perusahaan	ANDAMAN MEDICAL PHILIPPINES CORPORATION
Posisi	Regulatory Affairs Specialist - Indonesia
Tempat	Jakarta Timur
Tingkatan Kerja	Pegawai (non-manajemen & non-supervisor)
Kualifikasi	Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Layanan Kesehatan, Praktisi/Asisten Medis
Gaji Min	Rp. 10.000.000
Gaji Max	Rp. 12.000.000

We Are Looking for Applicants Residing in Indonesia.

Andaman Medical is a young and fast-growing Medical Device Regulatory Affairs & Market Access consultancy. We specialize in the registration, authorized representation, importation, master distribution, quality assurance and compliance of medical device and in-vitro diagnostics (IVD) in Southeast Asia. Our clients are among the world’s leading Medical Device and IVD Manufacturers. Our dedicated experts are located in various SEA countries including Malaysia, Singapore, Thailand, Philippines, Vietnam, Cambodia and Indonesia.

Position Overview

This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Consultant is expected to drive best practices in office and administrative management within the organization to maximize efficiency and growth. The main responsibility is to proactively support the organization in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.

Regulatory:

• Investigating whether the Health Product is a medical device requiring registration with MOH, determining its risk classification and its route of submission.
• Preparing and submitting documents related to Initial, Renewal, Variations/Change Notification of medical devices, follow-up until approval process.
• Promptly inform manufacturer is there’s any feedback from Authority to ensure successful product registration.
• Communicating with customers in respond to their regulatory concerns.
• Maintain regulatory database for the Company.
• Preparation of Regulatory Intelligence Report by carrying out proper research relating to the regulatory intelligence topic.
• Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates to Marketing Manager.
• Assist sales team in discussion with client on regulatory related matters (when required).
• Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Liaising with external parties on matters relating to Indonesia medical device regulatory requirements.
• Carry out the reporting of post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
• Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.

Requirements:

• At least a Bachelor’s Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
• At least 2 years’ experience in the medical device industry and especially in regulatory
• Experience in transacting with NBTC in securing approval for Bluetooth connectivity devices would be an advantage
• Fluent in English language both spoken and writing since you will be working with a multicultural workforce and clients.

Skills/Abilities:

• Good management skills
• Excellent writing and verbal communication skills
• Good management skills
• Result oriented, can work with minimal supervision, and willing to assume increasing levels of responsibilities
• Computer literate with advanced skills in Microsoft Office (Word, Power Point, etc..)

Personal quality:

• At ease in working in a small structure, start-up-type, where tasks and responsibilities are in constant move
• Able to operate in a multicultural environment
• High level of autonomy at work, yet with profound team-spirit

Industry

• Medical Device

Employment Type

Full-time

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Kesehatan/Medis
• Ukuran Perusahaan: 1- 50 pekerja
• Waktu Proses Lamaran: 25 hari
• Tunjangan dan Lain-lain: Asuransi Gigi, Waktu regular, Senin - Jumat, Kasual (contoh: Kaos)
• Lokasi: PT. Andaman Medical Indonesia Menara Cardig