Director, Regulatory Affairs

Kelly Services is proud to offer a direct hire opportunity in the Norcross, GA area for a Director, Regulatory Affairs (Transfusion).    Director, Regulatory Affairs (Transfusion) Location: Norcross, GA (Hybrid flexibility) Industry: Medical Devices / Biologics Pay: $190-$220k About the Role We are seeking an experienced and strategic Director of Regulatory Affairs to lead regulatory initiatives for a global Transfusion portfolio. This individual will oversee the development and execution of global regulatory strategies, manage submissions across the U.S., EU, and international markets, and provide guidance to cross-functional teams to ensure compliance and successful product registrations. This role is ideal for a regulatory leader who thrives in a fast-paced, innovation-driven environment and enjoys driving strategy and collaboration across scientific, clinical, and quality teams. Key Responsibilities Lead regulatory strategy development and execution for all transfusion products, aligning with overall business and R&D goals. Oversee the preparation and submission of global regulatory documents, including IND, BLA, 510(k), TDF, and OUS dossiers. Serve as the primary liaison with regulatory agencies, including the FDA, EMA, and other international authorities. Evaluate and determine reportability of adverse events under FDA MDR, BPDR, and EU/EEA Medical Device Vigilance systems. Ensure ongoing compliance with FDA, IVDR (EU 2017/746), ISO 13485, ISO 14971, and Good Clinical Practices (GCP). Provide leadership, mentorship, and strategic direction to the Regulatory Affairs team. Partner with cross-functional teams to guide product development, clinical trial design, and market access strategy. Monitor and interpret evolving global regulations, ensuring proactive adaptation of company policies and procedures. Qualifications Education: Bachelor’s degree in a scientific, engineering, or related discipline required. Advanced degree (MS, PhD, MBA) preferred. Experience: Minimum 10 years of progressive regulatory affairs experience within the medical device or biologics industry. Minimum 7 years in a people management or leadership role. Proven experience with BLA or Class III device submissions, clinical studies, and quality systems implementation. Technical & Leadership Skills: In-depth knowledge of FDA, IVDR, and international regulatory requirements. Successful track record of authoring and leading 510(k), IND, and/or BLA submissions. Experience supporting multicenter clinical trials and FDA BIMO audits. Strong relationships with regulatory agencies and consultants. Excellent written and verbal communication skills; ability to clearly interpret and convey regulatory expectations. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint); Visio experience a plus. High integrity, attention to detail, and a continuous improvement mindset. Leadership Competencies Talent Development: Fosters professional growth and team development. Customer Focus: Prioritizes both internal and external stakeholder needs. Decision Making: Balances data-driven insight with sound judgment. Innovation: Encourages creative problem-solving and process improvement. Emotional Intelligence: Builds trust through empathy, transparency, and communication. Additional Information Travel Requirement: Up to 30% domestic and international travel. Employment Type: Full-time, permanent. Ready to make a global impact? Join a mission-driven organization advancing transfusion and diagnostic technologies through regulatory excellence. #P1 As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. 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