Project Manager (Clinical) – Registration

 Singapore

3-5 Years

 Bachelor

Share this job

Share on facebook
Share on linkedin
Share on whatsapp

Job Description

  1. Understand laws and regulations of medical devices of global registration. Responsible for the quality control and management of clinical evaluation testing of each projects in global registration. 
  2. Responsible for the design of clinical evaluation testing plan, follow up the progress of clinical test, and ensure that the clinical evaluation is carried out in strict accordance with the protocol, SOP and relevant regulations in international registration (e.g., ISO13485:2016, FDA QSR and EU MDR).
  3. Responsible for clinical evaluation test results collection, statistical analysis, summary and writing of clinical evaluation testing report.
  4. Work under Quality Assurance / Regulatory Affairs Department to understand international quality standards (ISO13485:2016, FDA QSR and EU MDR), standardize and implement SOP. Responsible for organizing, planning and writing SOP manual /WI/ Form and other technical documents.
  5. Work closely with machine learning team and product research and development team to understand product core technology, product functions and solutions. Responsible for writing technical documents for international product registration.

Job Requirements

  1. Bachelor degree or above in clinical medicine or pharmacy, Minimum Master/PhD and above in Engineering or Science.
  2. Strongly recommended for at least 3 years of experience, knowledge, ability, and quality as a Clinical Research Associate (CRA).
  3. Good scientific awareness and experience in writing technical and research papers.
  4. Good mathematical and Bio-statistical background, familiar with Python and other programming languages, able to write code to analyze statistical results will additional.
  5. Proficient in English, excellent organizational and communication skills, good communication skills in both Chinese and English, able to communicate and write clearly and concisely in English.  
  6. Careful and responsible, patient and meticulous, logical, team spirit, strong dedication and sense of responsibility.

+65 6821 1272

+65 6821 1272

BioMind Offices

China

Beijing BioMind Technology, Zhongguancun Medical Engineering Center, 10 Anxiang Road, 8th floor

Singapore

Hanalytics Pte Ltd 151 Lorong Chuan #03-01C, Lobby A, New Tech Park, Singapore 556741

Europe

Hanalytics SARL House of Biohealth 27-29, rue Henri Koch, L-4354 Esch/Alzette,Luxembourg

Copyright © 2021 BioMind All Rights Reserved | ISO 13485:2016 Certified Organisation | Privacy Policy | Terms of Use

Personal Information

    some sample text

    Book Demo

    Our staff will contact you as soon as possible.
    Looking forward to meeting you!

    Products you are interested in

    CONTACT US