Senior Regulatory & Quality Compliance Specialist in Buford

Senior Regulatory & Quality Compliance Specialist Company: Rad Source Technologies, Inc. Location: Buford, GA (on-site) Department: Quality / Regulatory Reports to: Director / Head of Quality & Regulatory Affairs Experience: 10+ years required About Us We design and manufacture advanced X‑ray and irradiation technology for medical, research, and industrial markets. Our systems are used worldwide, and quality and regulatory compliance are central to everything we ship. We’re looking for a seasoned regulatory and quality professional to serve as a senior pillar of our quality function — keeping us compliant and audit‑ready, and making sure our quality system is understood and followed across the entire company. The Role This is a senior, hands‑on position for a deeply experienced regulatory and quality professional. You’ll report to the Head of Quality & Regulatory Affairs and start as the go‑to expert and driving force behind our regulatory compliance and quality system — owning day‑to‑day regulatory compliance, contributing to our QMS policies and procedures, and ensuring every department actually adheres to the system in practice. This role is designed with a clear growth path. We’re looking for someone with the experience, judgment, and leadership capability to grow into full ownership of the quality function over time. What You’ll Do Serve as the company’s subject‑matter expert on regulatory compliance, ensuring ongoing conformance with FDA 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, and notified body / EU MDR requirements. Develop, review, and maintain QMS policies, procedures, and work instructions, keeping them current, practical, and aligned with applicable regulations. Drive company‑wide adherence to the QMS — partnering with every department to ensure procedures are understood, followed, and consistently applied in daily operations. Support FDA inspections, notified body audits, MDSAP audits, and ISO 13485 certification audits — preparing documentation, participating in audits, and helping coordinate timely, effective responses. Plan and conduct internal audits, monitor compliance, and elevate gaps and risks to Quality & Regulatory leadership. Manage CAPA, nonconformances, and audit‑finding follow‑up through to closure, ensuring root causes are addressed and corrective actions are effective. Support document control, design controls, risk management (ISO 14971), and training programs, and reinforce a culture of compliance across the organization. Provide regulatory guidance to engineering, manufacturing, and operations teams, and support regulatory submissions and maintenance as needed. What You Bring Minimum 10 years of regulatory and quality experience in the medical device industry. Deep, demonstrated knowledge of FDA 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, and notified body / EU MDR requirements — this is the heart of the role. Hands‑on experience supporting FDA inspections, MDSAP audits, and notified body audits, including preparation, hosting, and response. Strong command of QMS policy and procedure development, internal auditing, CAPA, design controls, and risk management. Proven ability to drive cross‑functional adherence to a quality system — influencing and holding other departments accountable without direct authority over them. Excellent communication skills and a collaborative, ownership‑minded approach. The leadership capability and ambition to grow into full ownership of the quality function — comfortable today as a senior contributor, with a clear trajectory toward leading the department. Bachelor’s degree in engineering, life sciences, or a related field. Nice to Have Experience with radiation‑emitting / electronic products and the associated FDA requirements (21 CFR 1020, electronic product radiation control). Certifications such as ASQ CQA / CMQ‑OE, RAC (Regulatory Affairs Certification), ISO 13485 Lead Auditor, or MDSAP Auditor. Experience with regulatory submissions (510(k), EU MDR technical documentation) and international product registrations. Background in a small‑to‑mid‑size manufacturing environment where you wear multiple hats. Why Join Us You’ll be a senior, trusted expert in a quality function that genuinely matters to the business — with real influence over how we stay compliant and how we operate, and direct access to leadership. Just as important, this is a role with room to grow: we want this position to be filled by someone capable of eventually taking over the quality function entirely. Prove yourself here and the path to leading the department is open. This isn’t a seat in a large bureaucracy; your expertise will shape the company every day. Compensation Compensation is competitive and will be based on the candidate's skills, experience, and qualifications. Benefits Monthly Benefit Allowance awarded to all employees. Comprehensive Benefits Package. 401(k) Match – 100 % up to 5 % / fully vested immediately. PTO and Holiday Pay. Opportunities for growth. Monday – Friday. Rad Source Technologies, Inc. is an equal opportunity employer where employment is based upon personal capabilities and qualifications without discrimination because of , , , , , , , veteran status, or any other protected characteristic as established by law. Disclaimer: This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer. #J-18808-Ljbffr Energy Jobline ZR