Regulatory Affairs Manager

JOB DESCRIPTION Summary/Objective The Regulatory Affairs Manager is key member of the Regulatory Affairs team to ensure continued regulatory compliance for all products. This position will lead a team and work with cross-functional teams and 3rd party test labs to ensure completion of product testing required for global approvals and license. The Regulatory Affairs Manager will coordinate the assimilation of documentation required for global product approvals/license including U.S. 510(k)''s, EU MDD certifications, Health Canada License, China FDA license, and other approvals as required. This team leader will also provide mentoring, leadership, and development of their direct reports. This position will be based out of the Ball Ground, GA area but will be a hybrid position. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Ensure product/process compliance with the requirements of ISO 13485, FDA QSR, MDD, TPED, MDSAP, etc.Assist in the review and implementation of internal regulatory procedures to ensure regulatory compliance to maintained or enhancedLead 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.Manage and maintain regulatory files based on regulatory (e.g. MDD, TPED, and PED, etc.) and post-market requirements 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 and associated reporting petenciesGood business ethicsCommunication ProficiencyPresentation SkillsCollaborationTeamwork OrientationProject ManagementTechnical CapacityWork 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 20% 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 degree5+ years of related experience requiredExperience with various Codes and Standards (ISO 13485, FDA QSR MDD, MDSAP, etc.) requiredWorking knowledge of EU MDR (2017/745) Experience with U.S. FDA 510(k) submittalsExperience and working knowledge with international product approvals.Good communication skills at all levels (written and verbal)Proven ability to work with cross-functional teams and in a project management environmentDemonstrated ability to plan and manage multiple tasks/projectsPreferred Education and Experience MBA or master''s degree.Related certifications commensurate with the role.Medical Device experience is preferred PI187636128

Created: 2025-10-04