Regulatory Affairs Specialist

Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical documentation in local PLM system and corresponding product registrations with FDA and EU Notified Body. Maintains databases as required. Supports regulatory compliance projects as assigned.

Responsibilities

Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.

Initiates, reviews and approves technical documentation, product labeling, and product instructions for use changes for compliance with applicable regulations.

Trains to and executes document management within local Product Lifecycle Management system and other electronic documentation systems as applicable.

Updates and maintains product registrations with US FDA and EU Notified Body to assure compliance with applicable global regulatory requirements.

Other activities as assigned.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.