Director of 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.
