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.