Global Regulatory Affairs Specialist — Medical Devices (Senior)

Katalyst CRO; West Chester (Chester County); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a Regulatory Affairs professional to prepare regulatory documentation for medical devices across US, Canada, and EU, with global registrations. You will support the FDA processes, maintain regulatory databases, and assist with project initiatives within a dynamic team.

Responsibilities include interfacing with development, reviewing documentation and labeling, and ensuring compliance with evolving regulatory requirements.

Qualifications

• BS degree in science or engineering required.
• 4–6 years regulatory experience in medical devices or related field.
• Knowledge of regulatory submissions (510(k), FDA, CE) and labeling requirements.

Responsibilities

• Compile, prepare, review and submit regulatory submissions to authorities.
• Monitor and respond to regulatory requests for orthopaedic devices.
• Interface with Product Development to obtain information for regulatory submissions.
• Review/approve labeling and change controls; maintain regulatory databases.

Skills

Written communication

Oral communication

Organizational skills

Detail oriented

Risk-benefit analysis

Education

BS in Science or Engineering

Job description

Katalyst CRO is seeking a Regulatory Affairs professional to prepare regulatory documentation for medical devices across US, Canada, and EU, with global registrations. You will support the FDA processes, maintain regulatory databases, and assist with project initiatives within a dynamic team.

Responsibilities include interfacing with development, reviewing documentation and labeling, and ensuring compliance with evolving regulatory requirements.