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● Quality Responsibilities
●  Log quality information, monitor and maintain quality tools/ tracker/
database in a timely manner (safety and quality feedback, training, CAPA, etc)
●  Provide administrative support in utilization of quality systems (training,
customer-relationship management, document and record management, etc)
●  Prepare and monitor distribution of safety and quality customer bulletins
●  Upload temperature data in the system and email results to stakeholders
●  Prepare product sticker artwork, update work instructions, and processing of
local modifications
●  Extract and analyze quality-related data, and process quality-related reports
●  Conduct routine quality updates to stakeholders and follow-up as needed
●  Upcoming: Consolidate field safety notice and adverse event information
and support in reporting to PH FDA
● Regulatory Responsibilities
●  Evaluates, prepares and submits product registrations to the Food and Drug
●  Manage regulatory documents in the database and document management
●  Monitors and consistently follows-up status of applications to achieve Market
Authorization approval
●  Assists in the classification of IVD products according to the new IVD regulation
●  Prepare a report and update on the status of regulatory submissions
●  Ensure timely notification of regulatory submissions, FDA queries and approvals
to the relevant stakeholder.
●  College graduate preferably with license and a degree in health sciences (i.e.
pharmacy, chemistry, biology, medical technology, Nursing, Physical Therapy,
Public Health etc)
●  Proficient in data entry, word processing, and spreadsheet applications
●  Strong oral and written communication skills
●  Strong ability to learn, navigate, and utilize internal systems and applications
●  Strong attention to details and highly-organized
●  Capability to work under pressure
●  Ability to multitask, prioritize, and manage time effectively
●  Ability to work independently and as a team member
●  Familiarity with Google Workspace (gMail, gMeet, gSheet, gSlides, gDocs, etc.)
is an advantage
●  Good work ethic (i.e. professional, responsible, cooperative, dedicated, etc.)
●  Prior experience in quality and/or In-vitro diagnostics registration is an
Interested applicants may send their updated CV to

Subject: [Applicant's Name] - [Position]