Regulatory Affairs Specialist III

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

Responsibilities

• The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices)
• The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards
• Develop regulatory strategies to achieve market clearance in an effective and efficient manner
• Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable:
• 510(k) and/or De Novo submissions for FDA
• Technical documentation for EU MDR compliance
• International product registration activities to meet business objectives
• Provide regulatory input to support product labeling
• Monitor new and changing regulatory requirements and ensure the business understands relevant impacts
• Lead corrective and preventive action (CAPA) efforts as assigned
• Product Development Support:
• Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions
• Change Control Management:
• Assess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations
• Audits and Inspections:
• Support and participate in internal and external audits and regulatory agency inspections
• Complete QMS training activities and provide regulatory expertise to continuous improvement activities
• Support Lean and Kaizen initiatives
• Comply with all company policies and procedures
• Assist with any other duties as assigned

Requirements:

• Bachelor of Science degree
• 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