What are the responsibilities and job description for the Regulatory Affairs Specialist position at CAIRE Inc.?
Summary/Objective
The Regulatory Specialist is key member of the Regulatory Affairs team to ensure continued regulatory compliance for all products. This position will work with cross-functional teams and product design to ensure products continue to meet state of the art regulatory compliance and are labeled correctly. The Regulatory Specialist will coordinate the assimilation of documentation required for the EU Medical Device Regulation transition and maintenance of Technical Files and risk files.
This position will be based out of the Canton/Ball Ground location of Caire, which is approximately 30 minutes north of the greater Atlanta, GA area.
Essential Functions
Ensure product/process compliance with the requirements of ISO 13485, FDA QSR, MDD, TPED, MDSAP, etc. through review and approval Engineering Change Orders for compliance with Design Control Requirements.
Lead in the effort to secure the conversion from MDD to MDR and CE to UKAS by generating supporting documentation (technical files, reports, etc.) for all products.
Work with Engineering on new product releases and changes to develop Regulatory Plans including required testing, approvals, labeling and post market reporting.
Assist with audit support for 3rd party, notified body and regulatory authority audits. Lead on the internal audit team as needed.
Manage and maintain complaint file processing and facilitate transfer of this function to Quality.
Train as a MasterControl power user with admin function to provide back-up for the MC team.
Lead in Regulatory Team meetings assuming additional projects and tasks as required.
Competencies
- Good business ethics
- Communication Proficiency
- Presentation Skills
- Collaboration
- Teamwork Orientation
- Project Management
- Technical Capacity
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 in from a four-year college or university, preferably an engineering or technical degree
- 3 years of related experience required
- Experience with various Codes and Standards (ISO 13485, FDA QSR MDD, MDSAP, etc.) required
- Working knowledge of EU MDR (2017/745)
- Good communication skills at all levels (written and verbal)
- Proven ability to work with cross-functional teams and in a project management environment
- Demonstrated ability to plan and manage multiple tasks/projects
Preferred Education and Experience
- MBA or master’s degree.
- Related certifications commensurate with the role.
- Experience with U.S. FDA 510(k) submittals
- Experience and working knowledge with international product approvals.
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.