Regulatory Affairs Manager

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

• In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more
• You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions
• Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management
• Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies
• Oversee and coach a team of regulatory professionals to support both strategic and operational objectives
• Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.)
• Define and execute submission strategies to meet timelines and business goals
• Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review
• Monitor changes in international regulatory environments and communicate impacts to internal teams
• Represent the company in industry groups or regulatory associations, where appropriate
• Support training and knowledge-sharing on country-specific regulatory requirements within the organization

Responsibilities

• In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more
• You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions
• Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management
• Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies
• Oversee and coach a team of regulatory professionals to support both strategic and operational objectives
• Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.)
• Define and execute submission strategies to meet timelines and business goals
• Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review
• Monitor changes in international regulatory environments and communicate impacts to internal teams
• Represent the company in industry groups or regulatory associations, where appropriate
• Support training and knowledge-sharing on country-specific regulatory requirements within the organization

Requirements

• BS/MS degree or equivalent experience required
• Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR
• Superior presentation skills when communicating with all levels of the organization, business partners, and external sources
• Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment
• Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.