Director, Regulatory Affairs
3 weeks ago
Director, Regulatory Affairs (Transfusion)Kelly Services is proud to offer a direct hire opportunity in the Norcross, GA area for a Director, Regulatory Affairs (Transfusion). Location: Norcross, GA (Hybrid flexibility) Industry: Medical Devices / Biologics Pay: $190-$220kAbout the RoleWe 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 ResponsibilitiesLead 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.QualificationsEducation: 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 SkillsIn-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 CompetenciesTalent 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 InformationTravel Requirement: Up to 30% domestic and international travel. Employment Type: Full-time, permanent.
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Director, Regulatory Affairs
6 days ago
Norcross, United States Kelly Full timeKelly 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...
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Director, Regulatory Affairs
2 weeks ago
Norcross, United States Kelly Services Full timeKelly 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...
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Director, Regulatory Affairs
14 hours ago
Norcross, United States Werfen Full timeJob Information Number ICIMS-2025-9057 Job function QA&RA Job type Full-time Location T&T - Norcross - Norcross, Georgia United States Country United States Shift 1st About the Position Introduction Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells,...
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Principal, Regulatory Affairs
2 weeks ago
Norcross, United States Georgia Staffing Full timePrincipal, Regulatory Affairs (Transfusion)Kelly Services is proud to offer a direct hire opportunity in the Norcross, GA area for a Principal, Regulatory Affairs (Transfusion). Principal, Regulatory Affairs IVD / Medical Devices Location: Norcross, GA Industry: Medical Devices / In Vitro Diagnostics Pay: $100k-$130kAbout the RoleWe are seeking a highly...
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Principal Regulatory Affairs Specialist
2 weeks ago
Norcross, GA, United States Mondo Full timeJob Title: Principal Regulatory Affairs Specialist Location-Type: Hybrid Preferred (Norcross, GA) - Open to remote or relocation for highly qualified candidates Start Date: ASAP Job Type: Direct Hire Compensation Range: $100,000 - $130,000 annually + bonus Job Description: Lead U.S. regulatory activities for pre-market submissions, ensuring full...
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Principal Regulatory Affairs Specialist
1 week ago
Norcross, GA, United States Mondo Full timeJob Title: Principal Regulatory Affairs Specialist Location-Type: Hybrid Preferred (Norcross, GA) - Open to remote or relocation for highly qualified candidates Start Date: ASAP Job Type: Direct Hire Compensation Range: $100,000 - $130,000 annually + bonus Job Description: Lead U.S. regulatory activities for pre-market submissions, ensuring full...
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Principal Regulatory Affairs Specialist
7 days ago
Norcross, GA, United States Mondo Full timeJob Title: Principal Regulatory Affairs Specialist Location-Type: Hybrid Preferred (Norcross, GA) - Open to remote or relocation for highly qualified candidates Start Date: ASAP Job Type: Direct Hire Compensation Range: $100,000 - $130,000 annually + bonus Job Description: Lead U.S. regulatory activities for pre-market submissions, ensuring full...
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Principal, Regulatory Affairs
5 days ago
Norcross, Georgia, United States Werfen North America Full time $120,000 - $180,000 per yearPosition SummaryResponsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) 217/46, as well as other country regulatory agencies. Represents regulatory on design teams, prepares regulatory plans, authors US FDA 510(k)s, Health Canada license and EU Notified Body submissions and...
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Principal, Regulatory Affairs
16 hours ago
Norcross, United States Werfen Full timeJob Information Number ICIMS-2025-9058 Job function QA&RA Job type Full-time Location T&T - Norcross - Norcross, Georgia United States Country United States Shift 1st About the Position Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the...
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Principal, Regulatory Affairs
1 week ago
Norcross, United States Werfen Full timeJob Information Number ICIMS-2025-9058 Job function QA&RA Job type Full-time Location T&T - Norcross - Norcross, Georgia United States Country United States Shift 1st About the Position Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the...
