Regulatory Affairs Manager

Position: Sr. Manager, Regulatory Affairs Location: Atlanta, GA Salary: $150,000 + 10% bonus. Exact compensation may vary based on several factors, including skills, experience, and education. The Senior Manager, Regulatory Affairs will own and drive all regulatory activities across the product lifecycle for our regulated products portfolio. The role will ensure compliance with U.S. regulations (e.g., 21 CFR Part 820) and global standards (e.g., ISO 13485, ISO 14971), support future expansion into international markets and higher classification devices, and serve as a strategic regulatory partner to senior leadership. This role is critical to the company’s next phase of growth and will lead a significant overhaul of regulatory processes, ensuring the organization is prepared for increased regulatory scrutiny, expanded product claims, and future global market access. This individual will operate in a lean, evolving environment, where ambiguity is common and ethical decision-making is paramount. The successful candidate will be hands‑on, pragmatic, and capable of building structure where little currently exists, while serving as a strategic regulatory partner to senior leadership. This role is an individual contributor with the opportunity to grow into people leadership. Required Qualifications Bachelor’s degree in a scientific, engineering, regulatory, or related field (advanced degree preferred) 5+ years of Regulatory Affairs experience in the medical device industry Strong experience with FDA Class I devices , with demonstrated exposure or readiness for Class II environments Deep working knowledge of: FDA regulations (21 CFR Part 820), ISO 13485 and ISO 14971 Experience interacting directly with regulatory authorities High ethical standards and sound judgment when operating in ambiguous or evolving regulatory situations Proven ability to build processes from the ground up in a growing organization Preferred Qualifications RAPS Regulatory Affairs Certification (RAC) Experience with: Experience preparing for and presenting during ISO 13485 / MDSAP audits Hands‑on experience preparing and submitting 510(k)s and global regulatory dossiers #J-18808-Ljbffr