Epicareer Might not Working Properly
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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
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Jobs or company...

Regulatory Specialist - Medical Device

Salary undisclosed

Apply on

JobStreet
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Simplified

Responsibilities

  • Keeping up-to-date with the Company's product range. Prepare and submit regulatory submittals for market clearance, licensing and registration to US FDA.
  • Compile and review technical file for EU MDR to obtain/maintain CE marking.
  • Assist in tracking standards, regulations and all applicable requirements, and feedback to the management.
  • Assist in interactions regarding regulatory affairs with all functional areas of the company as required.
  • Stay updated on new and existing regulations, guidance documents, and standards, and communicate their impact on products and business to clients and internal teams.
  • Support in specifying labelling and packaging requirements for compliance with US, EU, International submissions and applicable regulations.
  • Work closely with the Notified Body to approve Change Notifications for medical devices.
  • Participate in company regulatory and quality audits when required.
  • Assist in executing international product registrations according to individual country specific requirements
  • ·Collaborate with cross-functional teams to ensure regulatory compliance at all stages of the product lifecycle.
  • As and when requested carryout other regulatory tasks delegated by the manager.

Requirements:

  • Minimum 3 - 4 years work experience in Regulatory Affairs for medical device products
  • Possess at least a Bachelor’s Degree in Science from an accredited university
  • Excellent verbal and written communication skills with strong English language proficiency
  • Extensive knowledge of quality management system, ISO13485, 21CFR820, MDD93/42/EEC, MDR, MDSAP and applicable standards issued by the International Standards Organization (ISO).
  • Strong computer skills required (including but not limited to Windows and Ms Office).
  • Exceptional ability to work independently with minimal supervision, effectively organise, priorities and manage multiple projects
  • Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work-related issues.
  • Positive attitude, strong attention to detail and ability to solve problems independently
  • Comprehensive understanding of regulatory activities and how they impact other products and/or processes
  • Based in KL office, willing to exhibit flexibility in working hours to cater for the communications with the UK office.
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