Global Medical Device Regulatory Affairs Specialist

Katalyst CRO; Seattle (WA); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking an experienced Regulatory Affairs professional to drive submissions for U.S. and European medical devices. You will guide product development with regulatory input, coordinate inputs across R&D, Quality, Medical, and Manufacturing, and ensure compliance with 21 CFR 820 and ISO 13485.

The ideal candidate holds a B.S. in life sciences or engineering, 2–5 years of device regulatory experience, RAC certification, knowledge of 510(k) and EU MDR/MDD, plus strong communication

Qualifications

• B.S. degree or higher in life science or technical discipline.
• 2-5 years Medical Device experience.
• Working knowledge of industry consensus standards and FDA guidance.
• Regulatory Affairs experience in Medical Device regulations (FDA/EU).
• RAC (RAPS) certification.
• Strong communication and project management skills.
• Proficient in Microsoft Office.
• Ability to manage multiple tasks and attention to detail.

Responsibilities

• Prepare regulatory submissions for U.S. and Europe to market medical devices.
• Represent RA on project teams and review design control docs.
• Support International Product Registrations and changes.
• Coordinate registration information with R&D, Quality, Medical, Manufacturing.
• Assess need for 510(k) and prepare non-filing justifications.
• Prepare/update technical files for CE marking with input from functions.
• Submit notifications to EU Notified Body for CE changes.
• Maintain regulatory documentation and support special projects.

Skills

Regulatory Affairs

FDA guidance

510(k) knowledge

EU CE marking

RAC certification

Project management

MS Office

Communication skills

Multitasking

Attention to detail

Education

Life science/Engineering degree

Job description

Katalyst CRO is seeking an experienced Regulatory Affairs professional to drive submissions for U.S. and European medical devices. You will guide product development with regulatory input, coordinate inputs across R&D, Quality, Medical, and Manufacturing, and ensure compliance with 21 CFR 820 and ISO 13485.

The ideal candidate holds a B.S. in life sciences or engineering, 2–5 years of device regulatory experience, RAC certification, knowledge of 510(k) and EU MDR/MDD, plus strong communication