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Bachelor

$18K-23K/Mth

Build and execute global regulatory strategy

Experience with FDA, NMPA, MDR a plus

Bachelor's degree in Life Science, Biotechnology, Engineering

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1 to 3 years


Bachelor

$30K-45K/Mth

University degree in Laws (LLB) or related disciplines

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至少3年藥品註冊工作經驗,具備東南亞國家註冊成功案例者優先

熟悉越南、泰國、馬來西亞、印尼等國的藥品註冊流程與法規要求

彈性工作安排(可選擇全職或兼職)

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Less than 1 year


Bachelor

$21K-23K/Mth

Assist in formulating Compliance policies

Degree in Business Administration, Law, or related

Good command in English and Chinese

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5 to 10 years


Bachelor

$37K-43K/Mth

Ensure operations meet ISO 13485, CE Mark, FDA 510(k), NMPA requirements

At least 8 years experience, 3+ years QA leadership in medical devices

Fluent in English, Cantonese, and Mandarin required

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5 to 10 years


No degree required

$40K-70K/Mth

5+ years BA/PM experience in large investment banks

Advanced SQL & Excel Macro skills

Deep knowledge of Corporate & Investment Banking products

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1 to 3 years


Bachelor

$20K-23K/Mth

Assist in formulating Compliance policies

Degree in Business Administration, Law, or related

Good command in English and Chinese

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1 to 3 years


Bachelor

$21K-22K/Mth

相關學科學士學位要求

監管合規經驗優先

ACOP認證優先考慮

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1 to 3 years


Bachelor

$21K-22K/Mth

Experience in regulatory compliance preferred

Degree in Business Administration, Law, or related

Good command of English, self-motivated, excellent communication skills

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3 to 5 years


Higher Diploma or Associate Degree

$25K-35K/Mth

University degree in Business Administration, IT or related field

Minimum 2 years experience in IT Asset Management or related domain

Strong skills in Microsoft Excel, Visio, and PowerPoint

Classy Wheeler

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Regulatory Affairs Associate (Medical)

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Micromag Healthcare Limited
Healthcare & Wellness
Posted 3 months ago
HK $18K-23K/Month
Bachelor
No experience limit
Work visa required
Full Time
5 days/wk

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Job Description

As our first dedicated Regulatory Affair Associate, you will play a pivotal hands-on role in building and executing our global regulatory strategy.

Responsibilities:

· Manage device classification, predicate selection, substantial equivalence argument, and labeling requirements.

· Support clinical and performance evaluation strategy, including liaison with CROs and clinical investigators.

· Prepare, compile, and submit regulatory dossiers

· Lead the creation and maintenance of Technical Files, Design Dossiers, Risk Management Files, Clinical Evaluation Reports, and Post-Market Surveillance plans

· Collaborate closely with R&D, Quality, and Clinical teams to ensure design control and risk management inputs are regulatory-compliant from the start.

Requirements:

· Bachelor's degree in Life Science, Biotechnology, Engineering, or related disciplines.

· Experience with regulator frameworks (FDA, NMPA, MDR, …) and documentation will be a big plus

· Excellent organizational, communication, and coordination skills.

· Manage multiple priorities in a deadline-driven environment without micromanagement

· Team player with great interpersonal skills and a strong sense of ownership


Languages
Mandarin
Cantonese
English
Skills
Risk Analysis
Regulatory Affairs
Medical Affairs

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Wai Shing Liu
Micromag Healthcare Limited · Director & CEO
Online

Job Location

The Chinese University of Hong Kong (CUHK)-Ma Liu Shui, Sha Tin

The Chinese University of Hong Kong, Central Ave, Ma Liu Shui, Hong Kong

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Company Overview

Micro stands for the micro-scaled miniature materials and chemicals; Mag stands for magnetic technology. MicroMag Healthcare Limited (MicroMag) is dedicated to weaving engineering research and medical applications together and preventing outbreaks of infectious diseases by providing a rapid, accurate, fully automated diagnosis with our novel microrobotic technology, such that timely treatment is possible by prompt screening. MicroMag is currently collaborating with experts from the Department of Mechanical and Automation Engineering at The Chinese University of Hong Kong, the Department of Microbiology at the Chinese University of Hong Kong, Lee Kong Chian School of Medicine at the Nanyang Technological University, and the Institute of Digestive Disease.


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