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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.
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  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.
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  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.
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  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).
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Jobs or company...

POST MARKET SURVILLANCE / Regulatory Specialists

Salary undisclosed

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Role: Post Market Surveillance / Regulatory Specialist

Key Responsibilities

  • Post Market Surveillance:
    • Collect, analyze, and report post-market data for medical devices, including complaints, adverse events, and device performance.
    • Maintain and update Post Market Surveillance (PMS) plans and reports according to regulatory requirements (EU MDR, FDA).
    • Investigate product complaints and conduct risk assessments for field actions such as recalls or safety notices.
    • Identify trends in post-market data to ensure timely corrective and preventive actions (CAPA).
  • Regulatory Compliance:
    • Ensure compliance with FDA (21 CFR Part 820), EU MDR (Regulation (EU) 2017/745), ISO 13485, and other applicable regulatory requirements.
    • Support the development, submission, and maintenance of regulatory filings such as 510(k), PMA, CE marking, and Technical Files.
    • Prepare and submit Medical Device Reports (MDR) and Vigilance Reports (EU) within regulatory timelines.
    • Work closely with cross-functional teams to ensure compliance with global post-market surveillance regulations.
  • Complaint Handling and Reporting:
    • Manage the complaint handling process, including investigation, root cause analysis, and customer follow-up.
    • Collaborate with engineering, quality, and manufacturing teams to resolve product issues identified through post-market data.
    • Prepare and review regulatory submissions, ensuring compliance with regulatory standards.
  • Risk Management:
    • Conduct post-market risk assessments and coordinate safety reviews.
    • Ensure documentation and reporting of safety and performance data in accordance with risk management processes (ISO 14971).
  • Continuous Improvement:
    • Participate in process improvements related to post-market surveillance, regulatory compliance, and complaint handling systems.
    • Support audits (internal and external) and regulatory inspections.
Qualifications:
  • Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
  • 2+ years of experience in Post Market Surveillance, Regulatory Affairs, or Quality Assurance in the medical device industry.
  • Solid understanding of regulatory requirements, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and ISO 14971.
  • Experience with post-market surveillance activities, complaint handling, and reporting of adverse events for medical devices.
  • Familiarity with regulatory submission processes (510(k), PMA, CE marking, etc.).
  • Strong analytical skills and ability to interpret and apply regulatory guidance.
  • Excellent communication skills, both written and verbal.
  • Strong organizational and project management skills.
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