Senior Regulatory Affairs Specialist - Medical Devices

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

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