Pharmacist in Charge - Regulatory Affairs (Medical Devices, …, San Juan

Description

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

Highlights

Company name

Omnibus Bio-Medical System Inc.
Job position

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

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