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Caleb Ng Email & Phone Number

Quality Assurance and Regulatory Affairs Manager at PainChek
Location: Australia, Australia, Australia 7 work roles 6 schools
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Current company
PainChek
Role
Quality Assurance and Regulatory Affairs Manager
Location
Australia, Australia, Australia
Company size
37 employees

Who is Caleb Ng? Overview

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Quick answer

Caleb Ng is listed as Quality Assurance and Regulatory Affairs Manager at PainChek, a company with 37 employees, based in Australia, Australia, Australia. AeroLeads shows a matched LinkedIn profile for Caleb Ng.

Caleb Ng previously worked as Quality Assurance/ Regulatory Affairs Manager at Painchek and Quality Systems Lead Auditor cum Technical Documentation Assessor at Tüv Süd. Caleb Ng holds Master'S Degree from Nanyang Technological University.

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PainChek

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Profile bio

About Caleb Ng

Key skills:- Set up, implement and maintain Quality Management System (QMS) in compliance to EU MDR, ISO 13485, FDA CFR Part 820 QSR, MDSAP, Japanese J-QMS and other regulatory requirements. - Lead implementation of ISO 27001 Information Security Management System- Achieved product market authorisation approvals to allow market access and clinical use in Australia, New Zealand, Singapore, Canada, Europe, United Kingdom, United States, ASEAN, etc.- Expert knowledge in medical device regulatory requirements- Planning, preparing and writing Technical Documentation for MD product registration - Expert in preparing and fronting FDA inspections, audits from Notified Bodies and other regulatory bodies. - Expert in QMS auditing- ASQ Certified Software Quality Engineer/ Manager- Certified workplace trainer - Certified curriculum and courseware designer

Current workplace

Caleb Ng's current company

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PainChek
Painchek
Quality Assurance and Regulatory Affairs Manager
Australia
Website
painchek.com
Employees
37
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7 roles · 20 years

Caleb Ng work experience

A career timeline built from the work history available for this profile.

Quality Assurance And Regulatory Affairs Manager

Painchek

Australia

Quality Assurance/ Regulatory Affairs Manager

Current
Painchek

Australia

PainChek Universal is a complete point-of-care solution that combines the existing PainChek® App with the Numerical Rating Scale (NRS) and data from PainChek® Analytics. This enables best-practice pain management for all residents living with pain in any environment — from those who cannot verbalise pain to those who can, and those who fluctuate between.

Sep 2020 - Present

Quality Systems Lead Auditor Cum Technical Documentation Assessor

Current
Tüv Süd

Singapore

- Lead Auditor for MDSAP, EU MDD/MDR, ISO 13485, ISO 9001- Technical Documentation Assessor (EU MDR/MDD)- Medical Device Regulatory Affairs Trainer

2012 - Present ~14 yrs 5 mos

Senior Quality Assurance Engineer

Nanosonics Ltd.

Sydney, New South Wales, Australia

- Established EU MDR compliant QMS- Established Computerized Systems Validation (CSV) Processes- Established EU MDR Economic Operators related Supplier evaluation, Agreement establishment, and performance monitoring processes

Oct 2019 - Sep 2020

Corporate Qa/Ra Manager (Regulatory Compliance Officer)

Sanmina

- Led and established MDSAP compliant QMS across Medical Device manufacturing facilities globally - Establish, implement and maintain Quality System complying to FDA Part 820, ISO 13485, J-QMS, EU MDD- Quality System Trainer- Quality Auditor- Regulatory Affairs

2015 - 2019 ~4 yrs

Academic Manager (Biomedical Electronics Engineering)

Republic Polytechnic

Singapore

- Manager for Embedded Systems Laboratory- Principle Investigator for Staff Development Project, titled "Intelligent Auditory Brainstem Response (ABR) Embedded Device"- Design and Development

2006 - 2012 ~6 yrs
Team & coworkers

Colleagues at PainChek

Other employees you can reach at painchek.com. View company contacts for 37 employees →

AH Andrew Hoggan Andrew Hoggan Colleague at PainchekGreater Sydney Area, Australia View → CS Catherine Smith Catherine Smith Colleague at PainchekCharmhaven, New South Wales, Australia, Australia View → EI Emmanuel Isaac Emmanuel Isaac Colleague at PainchekGreater Sydney Area, Australia View → DH Drew Hunt Drew Hunt Colleague at PainchekLondon, England, United Kingdom, United Kingdom View → TT Terry Taylor Terry Taylor Colleague at PainchekPolesworth, England, United Kingdom, United Kingdom View → MB Matias Berbis Matias Berbis Colleague at PainchekGreater Sydney Area, Australia View → IT Ida To Ida To Colleague at PainchekGreater Sydney Area, Australia View → JB Jeff Brooks Jeff Brooks Colleague at PainchekGreater Melbourne Area, Australia View → KN Khush Najran (Née Sohal) Khush Najran (Née Sohal) Colleague at PainchekSolihull, England, United Kingdom, United Kingdom View → AS Amran Sanghera Amran Sanghera Colleague at PainchekCoventry, England, United Kingdom, United Kingdom View →
6 education records

Caleb Ng education

Diploma In Adult And Continuing Education (Dace)

Institute Of Adult Learning

Regulatory Affairs Certificate

Regulatory Affairs Professional Society (Raps)

Advance Certificate In Training And Assessment (Acta)

Workforce Development Agency (Wda)
FAQ

Frequently asked questions about Caleb Ng

Quick answers generated from the profile data available on this page.

What company does Caleb Ng work for?

Caleb Ng works for PainChek.

What is Caleb Ng's role at PainChek?

Caleb Ng is listed as Quality Assurance and Regulatory Affairs Manager at PainChek.

Where is Caleb Ng based?

Caleb Ng is based in Australia, Australia, Australia while working with PainChek.

What companies has Caleb Ng worked for?

Caleb Ng has worked for Painchek, Tüv Süd, Dqs Australia New Zealand, Nanosonics Ltd., and Sanmina.

Who are Caleb Ng's colleagues at PainChek?

Caleb Ng's colleagues at PainChek include Andrew Hoggan, Catherine Smith, Emmanuel Isaac, Drew Hunt, and Terry Taylor.

How can I contact Caleb Ng?

You can use AeroLeads to view verified contact signals for Caleb Ng at PainChek, including work email, phone, and LinkedIn data when available.

What schools did Caleb Ng attend?

Caleb Ng holds Master'S Degree from Nanyang Technological University.

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