Senior Regulatory Affairs Lead, Medical Devices (510(k)/CE)

Katalyst CRO; Chicago (IL); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO in Chicago is seeking a Senior Regulatory Affairs Specialist to manage global product registrations for medical devices, including software as a medical device, and ensure regulatory compliance across design, manufacturing, and sales.

You will lead regulatory strategies, prepare submissions for FDA (510(k)/De Novo) and EU MDR, and coordinate international registrations while supporting labeling, quality systems, and continuous improvement initiatives.

Qualifications

• 57 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices
• Current experience leading multiple successful 510(k) clearances and CE marking is required
• Strong understanding of medical device product life cycle and regulatory requirements
• In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR
• Knowledge of ISO 14971 risk management for medical devices
• Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis
• Understanding of continuous improvement principles
• Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies
• Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions
• High level of attention to detail and accuracy, particularly when preparing regulatory submissions

Responsibilities

• Obtain and maintain regulatory approvals for medical devices globally (Class I and II) including software as a medical device
• Develop regulatory strategies to achieve market clearance efficiently
• Prepare, submit, and maintain registrations, certifications, and approvals per US, EU, and other regs
• Submit 510(k) and/or De Novo submissions for FDA
• Prepare technical documentation for EU MDR compliance
• Oversee international product registration activities to meet business objectives
• Provide regulatory input for labeling and lifecycle considerations
• Monitor regulatory changes and assess impact on business
• Lead CAPA efforts and support continuous improvement
• Support product development lifecycle and design controls with regulatory input
• Manage change control and assess regulatory impacts of design/manufacturing changes
• Support audits and regulatory inspections
• Complete QMS training and participate in audits

Skills

Regulatory affairs

FDA regulations

ISO 13485

EU MDR

510(k) submissions

De Novo submissions

Regulatory strategy

QA and CAPA

Regulatory documentation

Analytical thinking

Education

Bachelor of Science degree

Tools

Microsoft Excel

Database systems

Job description

Katalyst CRO in Chicago is seeking a Senior Regulatory Affairs Specialist to manage global product registrations for medical devices, including software as a medical device, and ensure regulatory compliance across design, manufacturing, and sales.

You will lead regulatory strategies, prepare submissions for FDA (510(k)/De Novo) and EU MDR, and coordinate international registrations while supporting labeling, quality systems, and continuous improvement initiatives.