Omnibus Bio-Medical System Inc. Pharmacist in Charge - Regulatory Affairs (Medical Devices, Reagents, and Machines)

Omnibus Bio-Medical System Inc.

NT$15.4-25.7K[月薪]

现场办公 - 圣胡安5-10年工作经验本科全职

Regulatory Submissions: Prepare, review, and submit product registration applications for medical devices, diagnostic reagents, and medical equipment to the Philippine FDA.
Compliance Monitoring: Ensure that all products comply with the regulatory requirements of the Philippine FDA, including standards for safety, efficacy, and labeling of medical devices and machines.
Product Documentation: Maintain and update technical documentation, product dossiers, and ensure timely submission of regulatory documents and reports.
Liaison with FDA and Authorities: Serve as the primary point of contact with the Philippine FDA and other regulatory bodies to facilitate product approvals, renewals, and post-market surveillance activities.
Regulatory Strategy: Develop and implement regulatory strategies to optimize registration timelines and ensure smooth market access for new and existing products.
Cross-functional Collaboration: Work closely with the R&D, Quality Assurance, and Marketing teams to ensure all products meet regulatory requirements throughout their lifecycle.
Training and Updates: Stay informed on changes in local and international regulations and provide regulatory training and updates to internal teams.
Department: Regulatory Affairs
Reports To: Regulatory Manager

Licensed Pharmacist in the Philippines.
Minimum of 5 to 10 years of experience in regulatory affairs, specifically with medical devices, reagents, or machines or in similar industry.
In-depth knowledge of Philippine FDA regulations related to medical devices, diagnostic reagents, and medical equipment.
Strong understanding of product registration processes and post-market compliance.
Excellent communication and interpersonal skills to liaise with regulatory bodies and internal teams.
Detail-oriented, with strong organizational and project management abilities.
Ages from 28 to 35

英语医药