QUALITY & REGULATORY SPECIALIST - BGC
Post Date:
Thursday, March 16 2023 to Tuesday, May 16 2023
JOB DESCRIPTION
● 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
Administration
● Manage regulatory documents in the database and document management
system
● 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.
QUALIFICATIONS
● 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
advantage
Interested applicants may send their updated CV to ydencomienda@knollridges.com.ph
Subject: [Applicant's Name] - [Position]
