Regulatory Affairs Specialist II — Medical Devices (US/EU)

Katalyst CRO; Boulder (CO); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking a Regulatory Affairs professional to prepare regulatory submissions for U.S. and European markets, support international registrations, and coordinate cross-functional inputs from R&D, Quality, Medical, and Manufacturing.

The role requires RAC certification, 2–5 years in medical devices, and strong knowledge of 510(k) and MDR/MDD, with attention to detail and excellent project management skills.

Competenze

• BS or higher in life science or technical discipline (engineering, bioengineering, biology, chemistry)
• 2–5 years medical device experience
• FDA guidance and industry standards knowledge
• 2+ years regulatory affairs experience in medical devices (FDA, EU)
• RAC certification (RAPS)
• Proficient in Microsoft Office
• Strong communication and project management
• Ability to manage multiple tasks
• Attention to detail
• Experience with 510(k), MDR/MDD
• Knowledge of 21 CFR 820 and ISO 13485

Mansioni

• Prepare regulatory submissions for U.S. and Europe to market medical devices.
• Support international product registrations and registrations/notifications.
• Coordinate with R&D, Quality, Medical, Manufacturing for registration information.
• Coordinate and collect registration inputs with cross-functional teams.
• Assess need for 510(k) filings for proposed device changes; prepare internal justifications.
• Prepare/update technical files for CE marking with cross-functional input.
• Submit CE-notifications to Notified Bodies for significant changes.
• Maintain regulatory documentation and support special projects.

Descrizione del lavoro

Katalyst CRO is seeking a Regulatory Affairs professional to prepare regulatory submissions for U.S. and European markets, support international registrations, and coordinate cross-functional inputs from R&D, Quality, Medical, and Manufacturing.

The role requires RAC certification, 2–5 years in medical devices, and strong knowledge of 510(k) and MDR/MDD, with attention to detail and excellent project management skills.