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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...

Regulatory Affairs Specialist

Salary undisclosed
Checking job availability...
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Role Overview

This position is responsible for handling product registrations and acting as the company’s regulatory liaison with relevant authorities. It involves researching regulatory frameworks, identifying pathways for approvals, and ensuring compliance. Additionally, the role collaborates with project teams to implement regulatory strategies, supporting timely market entry for products. A key aspect of this position includes reviewing labeling and marketing materials for regulatory adherence and contributing to quality system compliance by assessing design documents and implementing compliance strategies for emerging regulations and standards.

Key Responsibilities

  • Product Approvals & Compliance: Evaluate and document regulatory marketing requirements across different global markets. Manage application timelines, compile supporting documentation, and oversee submission and renewal processes based on applicable regulations. Handle various regulatory activities, including registrations, declarations, certifications, export documentation, and technical files. Maintain records within a centralized system and coordinate internally to resolve regulatory queries or deficiencies.
  • Regulatory Research & Intelligence: Stay updated on applicable regulations, industry standards, and evolving guidance in target markets. Track and analyze emerging regulatory changes, collaborating with subject matter experts to assess their impact. Contribute to developing strategies for compliance with new regulatory frameworks.
  • Strategic & Tactical Regulatory Management: Assist in formulating regulatory plans to support product development and enhancements. Execute regulatory strategies and approaches that align with business objectives.
  • Quality System & Compliance Support: Contribute to the development and updating of regulatory policies and procedures. Ensure proper documentation of regulatory workflows and assist other teams with audit and inspection preparation. Support assessments of new external standards for applicability to company operations.
  • General Compliance & Ethical Standards: Follow all established regulatory procedures, quality system regulations, and company policies, including environmental, safety, and HR requirements. Uphold company values through quality work and professional interactions.

Collaboration & Key Relationships

This role involves working closely with multiple internal teams, including Quality, Research & Development, and Affiliates, as well as external regulatory agencies and professional organizations.

Required Qualifications & Experience

  • Bachelor’s degree in life sciences, engineering, or a related field (advanced degree preferred).
  • Regulatory Affairs Certification is an advantage.
  • Minimum five years of experience in the in vitro diagnostics or medical device sector, with at least three years focused on regulatory functions.
  • Familiarity with regulatory submissions, including 510(k) applications and technical documentation for notified bodies.
  • Experience handling international product registrations.
  • Background in project management is a plus.

Skills & Competencies

  • Strong knowledge of regulatory requirements for in vitro diagnostics and medical devices, including global marketing authorizations and post-market vigilance.
  • Understanding of regulatory intelligence tools and their application in compliance strategies.
  • Experience with electronic publishing and file management systems.
  • Excellent verbal and written communication skills, including proofreading, scientific writing, and the ability to present persuasive arguments effectively.
  • Ability to influence and negotiate, fostering collaboration across teams.
  • Strong organizational skills, capable of managing multiple tasks in a fast-paced environment.
  • Analytical problem-solving skills with the ability to balance immediate regulatory needs with long-term strategic objectives.
  • Capacity to interpret complex scientific and regulatory topics to support decision-making.