Pharmacist in Charge - Regulatory Affairs (Medical Devices, Reagents, and Machines)

Omnibus Bio-Medical System Inc.

NT$15.3-25.5K[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
英語語言製藥
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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

發布於 09 January 2025

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