Regulatory Affairs Specialist III

Katalyst CRO; Richmond (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a Regulatory Affairs Senior Specialist to oversee global registrations and ensure regulatory compliance for medical devices, including Class I/II devices and software as a medical device. The role covers submissions, QMS alignment, and interpreting evolving standards across US, EU, and other regions.

Ideal candidates hold a BS degree with 5–7 years in medical device regulatory affairs, strong ISO/FDA/EU MDR knowledge, Excel/database proficiency, and excellent

Qualifications

• Bachelor of Science degree.
• 5-7 years of regulatory affairs experience in medical device industry.
• Strong understanding of medical device product life cycle and regulatory requirements.
• In-depth knowledge of ISO 13485, FDA regulations (21 CFR Part 820), and EU MDR.
• Knowledge of ISO 14971 risk management for medical devices.
• Proficiency in database systems and advanced Microsoft Excel for reporting and analysis.
• Understanding of continuous improvement principles.
• Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly.
• Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions.
• High level of attention to detail when preparing regulatory submissions.

Responsibilities

• Obtain and maintain regulatory approvals for global product registrations.
• Support QMS objectives and ensure adherence to regulatory standards.
• Develop regulatory strategies to achieve market clearance efficiently.
• Prepare, submit, and maintain registrations and approvals for US/EU/regional requirements.
• Manage 510(k) and De Novo submissions for FDA as applicable.
• Prepare technical documentation for EU MDR compliance and support labelling.
• Monitor regulatory changes and communicate impacts to the business.
• Lead CAPA efforts and participate in audits/inspections.
• Provide regulatory input throughout product lifecycle including design controls.
• Assess regulatory impacts of design/manufacturing changes and update registrations.

Skills

Regulatory affairs

Medical devices

Regulatory submissions

Quality systems

Regulatory strategy

Communication skills

Education

Bachelor of Science

Tools

Microsoft Excel

Database systems

Job description

• 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)
• The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards
• Regulatory Submissions and Compliance:
• 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 labelling
• 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, et al, including related updates to product registrations
• Audits and Inspections:
• Support and participate in internal and external audits and regulatory agency inspections.

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)
• The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards
• Regulatory Submissions and Compliance:
• 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 labelling
• 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, et al, including related updates to product registrations
• Audits and Inspections:
• Support and participate in internal and external audits and regulatory agency inspections.

Requirements:

• Bachelor of Science degree
• 5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices
• 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