Global Regulatory Affairs Specialist

CAIRE Inc.; Ball Ground (GA); On-site; USD 70,000 - 110,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

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

Education

Bachelor’s degree (engineering or technical)

Job description

As a Regulatory Affairs Specialist, you will work with the FDA and international regulatory bodies on product submissions, audits, and event reporting. You will participate in cross-functional teams for new product development and changes to existing products to ensure regulatory compliance. You will also be part of the team that maintains the quality management system.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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

Competencies/Success Factors

• 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

Supervisory Responsibility

This position has no supervisory responsibilities

This job operates in a professional office environment and manufacturing/distribution environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

This is largely a sedentary role; however, some activity is required. This would require the ability to lift, bend or stand as necessary.

Travel

This position requires up to 10% travel. Some of the travel may be international.

Required Education and Experience

• 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

Preferred Education and Experience

• Co-op or internship preferred

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.