Regulatory Officer

Health Solutions Enterprise Inc.; Pasig; On-site; PHP 600,000 - 800,000; Full time

Job summary

Health Solutions Enterprise Inc. in Pasig is looking for a pharmacist to manage regulatory compliance for medical devices. The role involves processing licenses, managing registrations, and ensuring adherence to FDA regulations.

Applicants should be licensed pharmacists with at least 2 years of experience in the regulatory field. The position requires strong communication skills and a detail-oriented approach. Most work will be onsite, with some field duties required.

Qualifications

• At least 2 years of work experience in the regulatory industry, preferably in Medical Devices & IVD Division.
• Experienced in dealing with FDA CDRRHR or Medical Devices.
• Knowledgeable and updated with government mandates related to medical devices.

Responsibilities

• Act as the representative ensuring compliance with regulations.
• Process License to Operate (LTO) applications.
• Liaise and coordinate with Principal Relations.

Skills

Detail-oriented

Good written and oral communication skills

Proficient in MS Applications

Education

Graduate of BS Pharmacy

Licensed or registered pharmacist

Job description

HealthSolutions Enterprises Inc. is a professional organization engaged in the importation, marketing, sales, and distribution of high‑quality, affordable medical disposables, devices, and equipment to health and industrial accounts in the Philippines.

Job Description

• Act as the representative/point person ensuring the company complies with all applicable regulations, particularly for product registration.
• Process License to Operate (LTO) applications, including initial LTO as importer and distributor of medical devices, and renew existing LTOs for FDA, NTC, and OMB.
• Renew and modify Certificate of Medical Device Notification/Registration (CMDN/CMDR) before expiration and apply CMDN/CMDR to all existing and new products.
• Handle brand name registration.
• Safekeeping, organizing, and filing of documents.
• Liaise and coordinate with Principal Relations.
• Process requirements for regulatory agencies.

Qualifications

• Graduate of BS Pharmacy.
• Licensed or registered pharmacist.
• At least 2 years of work experience in the regulatory industry, preferably in Medical Devices & IVD Division.
• Experienced in dealing with FDA CDRRHR or Medical Devices.
• Knowledgeable and updated with government mandates related to medical devices, especially FDA AO No. 2018‑002.
• Has attended at least one Licensing Seminar for Medical Device Establishments.
• Detail‑oriented, especially with document assessment.
• Good written and oral communication skills, especially when dealing with principals/business partners regarding documentary requirements for CPR processing.
• Proficient in MS Applications.

Additional Information

75% – work on site (Pasig Office)

20% – field work (FDA/NTC/OMB/RITM)

5% – reporting at warehouse (very minimal)

Job Location