Regulatory Affairs Specialist

Position Summary:

Supports and executes regulatory compliance processes in collaboration with cross-functional teams and leadership, ensuring alignment with NeoCoil’s QMS and applicable regulatory requirements. Supports departmental efforts for compilation and submission of applicable documents in accordance with NeoCoil QMS requirements and jurisdictional requirements.

Job Duties and Responsibilities:

• Acts as a liaison within NeoCoil for educating employees and stakeholders on regulations, procedures, and policies.
• Executes assigned regulatory processes, including administrative tasks, data analysis, trend identification, and reporting.
• Supports the evaluation of changes to regulations, international standards, customer requirements, products, processes, and QMS documentation.
• Identifies and communicates improvement opportunities and/or escalates weaknesses/gaps in product, process, and quality management system documents to ensure NeoCoil achieves and maintains the necessary levels of compliance.
• Maintains data and files for future reference, particularly in the event of an audit by a regulatory agency; assists in preparation/compilation of regulatory submissions.
• Executes core duties and responsibilities of the role in accordance with the established skills competencies.
• Performs Product Quality Engineer responsibilities as assigned, ensuring alignment with quality and regulatory expectations.
• All other duties, as assigned.