Registered Medical Technologist (Medical Device Management), San Juan

Description

Following to good storage and distribution practices, as well as other relevant and applicable practices;
Safeguarding that all medical devices offered for sale have the required authorization from the FDA;
Guaranteeing that the establishment complies with all existing FDA regulations and advisories on medical devices;
Needful appropriate authorization from the establishment's supplier/distributor before purchasing and selling medical devices;
Keeping well-versed about the full implementation of AO No. 2018-0002 (Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements and/or its subsequent amendment(s)) and other FDA policies/issuances on the regulation of medical devices, in coordination with the establishment's supplier/distributor;
Advisory services, including expert opinions and recommendations on issues relevant to business and potential future project acquisitions.

Educational Qualifications: Bachelors degree in a relevant field.
Experience Level: 1-3 years of experience in quality audit.
Skills and Competencies: Strong analytical skills, attention to detail, and proficiency in audit processes.
Responsibilities and Duties: Conduct quality audits, prepare reports, and ensure compliance with standards.
Working Conditions: Office-based environment with occasional travel.
Qualities and Traits: Proactive, reliable, and excellent communication skills.

Highlights

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