Cooperative Quality and Regulatory Affairs Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €20,000 - €30,000

Experience a dynamic and challenging environment with this quality and regulatory affairs role. Develop your knowledge of quality systems, regulatory frameworks, and legal requirements to drive improvement in the industry.

This position involves collaborating with experienced professionals to identify areas for improvement and develop strategies to address them. You will be an integral part of a team focused on ensuring compliance with quality and safety standards.

  • Conduct research and analysis to identify areas for improvement in quality and regulatory affairs.
  • Develop and implement plans to address these areas, working closely with colleagues and supervisors.
  • Communicate project updates and present at review forums to ensure seamless collaboration.

The ideal candidate will have a strong academic background in engineering, science, or a related field, as well as excellent analytical and problem-solving skills. Honesty, integrity, and self-motivation are also essential for success in this role.

Key Skills:

  • Quality Systems: Strong understanding of quality systems, including ISO 13485 and 21 CFR Part 820.
  • Regulatory Frameworks: Familiarity with regulatory frameworks, including EU Medical Device Directive 93/42/EEC and US FDA regulations.
  • Analytical and Problem-Solving Skills: Excellent analytical and problem-solving skills, with the ability to think critically and make sound decisions.

Benefits:

  • Professional Development: Opportunities for professional development and growth, including training and mentorship programs.
  • Collaborative Environment: Collaborative and supportive work environment, with opportunities to work with experienced professionals and contribute to high-profile projects.

Others:

  • Communication Skills: Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely.
  • Time Management: Strong time management and organizational skills, with the ability to prioritize tasks and meet deadlines.

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