Regulatory Product Lead: Medical Devices & Compliance

Janissa Healthcare Philippines, Inc.; Pasig; On-site; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary & benefits

Career growth and development

Healthcare industry experience

Job summary

Janissa Healthcare Philippines, Inc. is seeking a dual-functional Product Development & Regulatory Officer to lead our product lifecycle strategy and ensure 100% compliance with Philippine regulatory standards.

This role bridges suppliers, government agencies (FDA, PDEA, DOH), and the sales force from an on-site Pasig location. The ideal candidate has 4+ years of regulatory affairs experience in pharma or medical devices and must be a licensed pharmacist, with responsibilities spanning

Qualifications

• At least 4 years as Regulatory Affairs Officer in a Pharmaceutical or Medical Equipment company.
• Knowledge of processing, registering and renewal of product registrations with FDA and PDEA.
• Experience in importation and bid documents preparation is an advantage.
• Must be a Licensed Pharmacist.

Responsibilities

• Secure and maintain licenses and registrations (FDA, PDEA, DOH, BOC, etc.).
• Manage end-to-end collection of technical data from suppliers for pre-registration/renewals.
• Facilitate IPO registrations and monitor IP filings.
• Ensure facilities/ processes meet Good Warehousing Practices and SOPs.
• Lead R&D to identify and launch new medical products.
• Coordinate imports and logistics with suppliers, brokers, and forwarders.
• Support market launches with training materials for Sales & Marketing.
• Conduct monthly inventory audits and support demand forecasting.
• Assist in preparing documents for Government Bid opportunities.

Skills

Regulatory affairs

FDA registration

Documentation management

IP management

Quality assurance

Education

Licensed Pharmacist

Job description

Janissa Healthcare Philippines, Inc. is seeking a dual-functional Product Development & Regulatory Officer to lead our product lifecycle strategy and ensure 100% compliance with Philippine regulatory standards.

This role bridges suppliers, government agencies (FDA, PDEA, DOH), and the sales force from an on-site Pasig location. The ideal candidate has 4+ years of regulatory affairs experience in pharma or medical devices and must be a licensed pharmacist, with responsibilities spanning