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Regulatory Affairs Specialist

2 months ago

Manila, National Capital Region, Philippines Aljeron Medical Enterprises, Inc. Full time

Role Description

This is a full-time on-site role for a Regulatory Affairs Specialist at Aljeron Medical. The Regulatory Affairs Specialist will be responsible for handling regulatory documentation, ensuring regulatory compliance, and understanding and meeting regulatory requirements. He/She/They will be responsible for spearheading all regulatory activities in line with FDA requirements and act as a key liaison personnel between the company and FDA or any government and regulatory bodies.

Qualifications

Bachelor's degree in a related field, such as Life Sciences (Pharmacy, Biology, etc.)Licensed professional in related fieldsExperience in the medical device industry is a plusSkills in Regulatory Documentation, Regulatory Compliance, and Regulatory RequirementsAt least 1 year experience in Regulatory Affairs and Regulatory Submissions is preferredKnowledge of applicable regulations and guidelinesAttention to detail and strong organizational skillsExcellent written and verbal communication skillsAbility to work independently and collaborativelyResponsibilitiesStay updated on regulations and communicate with regulatory agencies/association such as the following: Food and Drug Administration (FDA), Center for Drug Regulation and Research, Center for Device Regulation, Radiation Health and Research, Center for Cosmetics and Household/Urban Hazardous Substances, Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP)Liaise with suppliers for legal and product documents for product registrationEnsure validity of legal documents and request updatesManage FDA licensing processes for initial, variation, and renewal applicationsNotify FDA of products not requiring registrationOrganize documents per FDA requirementsOversee FDA portal account renewalsCompany Description

Aljeron Medical Enterprises (AMEI) is a licensed servicer, importer, and distributor of various surgical, diagnostic, laboratory, and radiological equipment and devices. With a strong network and dedicated team, AMEI has grown to become a reputable company in the industry. Headquartered in Metro Manila, AMEI operates nationwide through its sales representatives, dealers, and biomedical engineers.