Global Regulatory Affairs Expert: FDA Submissions & Compliance

CAIRE Inc.; Ball Ground (GA); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

CAIRE Inc. is seeking a Regulatory Affairs Specialist to collaborate with the FDA and international bodies on product submissions, audits, and adverse event reporting.

You will participate with engineering, design, and development teams to ensure regulatory compliance for new products and changes to existing ones, and help maintain the quality management system. The role requires strong communication skills, attention to detail, and ability to manage multiple submissions and timelines.

Formación

• Bachelor’s degree from a four-year college or university, preferably an engineering or technical degree or equivalent work experience
• Good communication skills at all levels (written and verbal)
• Ability to plan and manage multiple tasks/projects

Responsabilidades

• Ensure product/process compliance with the US and international requirements
• Work with Engineering on new product releases and changes to develop Regulatory Plans
• Work with Design and Development Project teams to ensure compliance with Design Control Requirements
• Work with the FDA on product submissions
• Initiate US and International product submissions and registrations
• Participate in internal and external audits
• Reporting of adverse events to FDA
• Other duties as assigned

Conocimientos

Business or Job-Specific Knowledge

Learning Ability

Results Focus/ Output Orientation

Time Management

Interpersonal Communication

Handling Conflict or Difficult People

Ethics, Integrity, Values

Problem-Solving

Educación

Bachelor’s degree (engineering or technical)

Descripción del empleo

CAIRE Inc. is seeking a Regulatory Affairs Specialist to collaborate with the FDA and international bodies on product submissions, audits, and adverse event reporting.

You will participate with engineering, design, and development teams to ensure regulatory compliance for new products and changes to existing ones, and help maintain the quality management system. The role requires strong communication skills, attention to detail, and ability to manage multiple submissions and timelines.