Our manufacturing and engineering medical device customer in Ball Ground, GA is currently looking for a Regulatory Specialist to join their expanding operations on a permanent basis.
Sr. Regulatory Affairs Specialist
This is a Senior level person with experience 5 to 10 years in regulatory. Medical device experience in regulatory or a similar product experience.
Ensure product/process compliance with the requirements of ISO 13485, FDA QSR, MDD, TPED, CMDCAS, etc.
Lead the initial effort to secure the required product approvals including document submissions to regulatory authorities and notified bodies.
Proactively maintain existing approvals including submission of renewal paperwork.
Work with Engineering on new product releases and changes to develop Regulatory Plans including required testing, approvals, labeling and post market reporting.
Work with Engineering to develop and maintain MDD and TPED technical files.
Lead efforts to develop processes to ensure continued regulatory compliance for products and processes.
Work with Design and Development Project teams to ensure compliance with Design Control Requirements.
Assist with training in the business unit and satellite facilities to ensure personnel are familiar with and knowledgeable regarding regulatory requirements and reporting.
Experience and working knowledge with standards and test requirements associated with medical electrical equipment
Experience with various Codes and Standards (ISO 13485, FDA, QSR, MDD, TPED, CMDCAS, etc.) is preferred.
Experience with U.S. FDA 510K submittals as well as international medical device approvals.
Working knowledge and experience with ISO 13485 Quality Systems practices
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