Epicareer Might not Working Properly
Learn More
Please Turn on your JavaScript

Epicareer might not working properly because your browser javascript is turned off.

What is JavaScript?

JavaScript is like the magic behind making websites interactive. Basically, it makes Epicareer more enjoyable and engaging.
How do i turn this on?
Find tutorial for your browser below :
  1. Make sure the webpage is open.
  2. In the Safari app on your Mac, choose Safari > Preferences, then click Security.
  3. Make sure the Enable JavaScript checkbox is selected.
  4. Click Websites.
  5. On the left, click Content Blockers.
  6. Make sure Off is chosen in the pop-up menu next to the website.
  7. On the left, click Pop-up Windows.
  8. Make sure Allow is chosen in the pop-up menu next to the website.
Visit Site here
  1. Open Chrome on your computer.
  2. Click. then Settings.
  3. Click Privacy and Security.
  4. Click Site settings.
  5. Click JavaScript.
  6. Select Sites can use Javascript.
Visit Site here
  1. If you're running Windows OS, in the Firefox window, click Tools > Options.
  2. Tip: If you're running Mac OS, click the Firefox drop-down list > Preferences.
  3. On the Content tab, click the Enable JavaScript check box.
Visit Site here
  1. Click the "Settings and more" icon at the top right of the Edge browser window.
  2. Click Settings.
  3. From the Settings menu, click Cookies and site permissions.
  4. Scroll down and click on JavaScript.
  5. In the JavaScript window, toggle the slider to "on" or "allowed."
  6. Close the Settings tab.
  7. Refresh the page.
Visit Site here
  1. Go to Settings.
  2. Click Advanced in the left sidebar, and click Privacy & security.
  3. Under Privacy and security, click Site settings.
  4. Click JavaScript.
  5. At the top, turn on or off Allowed (recommended).
Visit Site here
Any Question? Contact us
logo
Jobs or company...

REGULATORY AFFAIR (COMPLIANCE)/ QA EXECUTIVE

Salary undisclosed
Checking job availability...
Original
Simplified

Curas Sdn. Bhd is a subsidiary of a British company, based in Butterworth, Malaysia. In line with our expansion plan and to support our worldwide operations in medical devices industry; we are seeking capable and dedicated individuals to join our dynamic organization for an exciting career in the below position. We offer challenging and supportive working environment with opportunities for career development.

REGULATORY AFFAIR (COMPLIANCE)/ QA EXECUTIVE

Responsibilities:

  • Provide ongoing consultation, handle enquiries and assessment relating to regulatory compliance and quality assurance issues to the management and its customers.
  • Developing, implementing and maintaining regulatory and quality system compliance programs and procedures in accordance with ISO 13485, ISO 9001, MDD/MDR/CE requirements, etc.
  • Management of medical device regulatory service programs, with good understanding of Authorized Representative and Importer role in Europe.
  • Prepare, compile and review Technical Files for CE Marking, Medical Device Files update, agreement, DOC, and other document for CE marking compliance.
  • Handle customer complaint, and have good understanding of Incident Reporting, Adverse Event and Recalls.
  • Schedule, lead and conduct yearly internal audits on quality system to ensure compliance to ISO/EN standards, CE, SOP requirement to secure continued compliance.
  • Coordinate various audits with relevant external auditors/notified body etc.
  • Provide update on international Norms which the company’s products must comply to.
  • Support and coordinate all regional or national product registration requirement, i.e. MDA, TGA, FDA, SFDA, ANVISA, etc.
  • Coach, guide and monitor subordinate performance on Regulatory and Quality Assurance Tasks.
  • Lead in yearly Management Review Meeting.

Requirements:

  • Degree in Science or any other related fields.
  • Minimum 2 years of working experience in regulatory compliance and/or quality assurance role, preferably in medical device sector.
  • Knowledge in implementation and maintenance of quality systems (i.e. ISO 13485, ISO9001, MDD/MDR, CE marking) preferred.
  • Excellent communication skill in English.
  • Have leadership capability, multi-tasking, result orientated, energetic, proactive, detail orientated and ability to work under stress.
  • Fresh graduate without experience but keen interest to be in this field are also welcome to apply for officer level.

Salary will commensurate with qualification and experience. Qualified and interested candidates are invited to apply online. Please include your resume and state your expected salary. Only short-listed candidates will be notified

Job Types: Full-time, Permanent, Fresh graduate

Pay: RM2,500.00 - RM4,500.00 per month

Benefits:

  • Free parking
  • Maternity leave
  • Opportunities for promotion
  • Professional development

Schedule:

  • Day shift
  • Monday to Friday

Supplemental Pay:

  • Yearly bonus

Application Question(s):

  • What is your hobby? Name at least 2.

Education:

  • Bachelor's (Required)

Experience:

  • regulatory/compliance or QA: 2 years (Required)
  • Auditing, QMS or ISO: 1 year (Required)

Language:

  • and write English fluently in a professional setting (Required)

Application Deadline: 01/24/2025
Expected Start Date: 02/01/2025

Similar Jobs

1d ago

Marketing Executive
HYDRO ONE MARKETING SDN BHD
Selayang, Malaysia

Full Time, onsite, onsite

RM 4,000 / Per Mon