Regulatory Officer

HealthSolutions Enterprises Inc., a professional organization established as a healthcare solutions provider. The Company is engaged in the importation, marketing, sales, and distribution of imported, high quality & affordable hospital, medical and laboratory disposables, devices, and equipment to the country’s health and industrial accounts and institutions. HSE is a Company that embraces harmony and balance between product quality and affordability. It focuses on the delivery of cost-effective medical products that benefit and answer the needs and wants of both the patients and medical practitioners.

Job Description

Regulatory Officer is to act as the representative/point person in ensuring that the company is compliant with all the applicable regulations, particularly for product registration, by any of the authority agencies in Philippines.

1. Process License to Operate (LTO) such as apply for initial LTO as importer and distributor of medical devices to any agencies applicable to company and renew existing LTO's for FDA, NTC and OMB.
2. Renew and change Certificate of Medical Device Notification/Registration (CMDN/CMDR) prior to expiration and apply CMDN/CMDR to all existing and new products.
3. Handle Brand name Registration
4. Provides Marketing Support documents
5. Safekeeping, organizing and filing of Documents
6. Liaise and coordinate with Principal Relations
7. Process requirements for Regulatory Agencies

Qualifications

Graduate of BS Pharmacy

Must be a licensed or registered pharmacist
At least 2 years' work experience in 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 most especially FDA AO No. 2018-002
Have attended at least once the Licensing Seminar for Medical Device Establishments
Keen to details specially with documents assessment
Good communication skills (written and oral) specially with Principals/Business partners especially in relation to 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)