Global Regulatory Affairs Lead — Medical Devices

Katalyst CRO; Atlanta (GA); On-site; USD 150,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking a Regulatory Affairs Lead to steer global regulatory strategies, submissions, and lifecycle management for advanced ultrasound devices. You will manage a team of regulatory professionals and coordinate with Clinical and Global Regulatory Affairs to ensure timely approvals in key markets including FDA, EU MDR, and NMPA.

The role demands strong communication, strategic thinking, and the ability to navigate evolving regulatory landscapes across multiple jurisdictions while

Qualifications

• BS/MS degree or equivalent experience required.
• Expertise with global medical device regulations and registration processes (FDA 510(k), EU MDR).
• Superior presentation and communication skills for all organizational levels.
• Ability to work with evolving technologies, systems, and global teams in a fast-paced environment.

Responsibilities

• Lead regulatory strategies, product submissions, and a regulatory affairs team to drive approvals across markets (USA FDA, EU MDR, China NMPA).
• Collaborate cross-functionally with Clinical and Global Regulatory Affairs to expand market access for ultrasound technologies.
• Develop and implement global regulatory strategies for new registrations and product lifecycle management.
• Oversee preparation and submission of regulatory dossiers to authorities (FDA, NMPA, EU Notified Bodies).
• Coach and develop a team of regulatory professionals to meet strategic and operational goals.
• Interpret regulatory requirements for medical devices (IEC/ISO, FDA 510(k), MDR, NMPA).
• Define submission timelines and act as liaison to authorities and stakeholders.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Communication

Education

BS/MS degree or equivalent experience

Job description

Katalyst CRO is seeking a Regulatory Affairs Lead to steer global regulatory strategies, submissions, and lifecycle management for advanced ultrasound devices. You will manage a team of regulatory professionals and coordinate with Clinical and Global Regulatory Affairs to ensure timely approvals in key markets including FDA, EU MDR, and NMPA.

The role demands strong communication, strategic thinking, and the ability to navigate evolving regulatory landscapes across multiple jurisdictions while