Job Description
Job Description
As a Quality Assurance & 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
Supervisory Responsibility
This position has no supervisory responsibilities
Work Environment
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
- Master’s degree a plus
- 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.