Pharmacist in Charge - Regulatory Affairs (Medical Devices, Reagents, and Machines)
Omnibus Bio-Medical System Inc.
HK$4.2-7K[月薪]
现场办公 - 聖胡安5 - 10 年經驗本科全職
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職位描述
簡介
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
職位要求
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
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Maxine C.
Admin OfficerOmnibus Bio-Medical System Inc.
活躍於三天內
工作地址
4/F, 4/F, Wilson Corporate Center, WSC Corporate Center, 225 Wilson, San Juan, 1502 Metro Manila, Philippines