Fluxergy Inc
Regulatory Specialist (Finance)
Filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Assisting in procedure development and deployment to ensure regulatory compliance.
Working independently and collaboratively in nature.
Being an individual contributor and subject matter expert responsible for creating and executing regulatory submissions for pre-market activities.
Supporting regulatory team in all global regulatory submission initiatives and collaborating with cross-functional teams as required.
This position requires a moderate to deep knowledge of regulatory compliance requirements, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485 (Medical devices -- Quality Management Systems), Medical Device Single Audit Program (MDSAP) and/or In Vitro Diagnostics Regulation (IVDR).
Responsibilities
Support regulatory team in conducting regulatory assessments and sustain current and market expansion regulatory registrations under IVDR, US FDA and other global regulations.
Collaborate cross-functionally (e.g., Quality Assurance, Research & Development, Product/Program Management, Marketing) to collect and coordinate information and regulatory documentation for regulatory submissions.
Collaborate cross-functionally in design control process to ensure regulatory requirements are met.
Create or manage technical files as required to obtain and sustain product registration.
Provide labeling requirements and review labeling and labels for regulatory compliance.
Compile and maintain regulatory documentation databases or systems.
Compile and maintain current regulatory standards.
Can lead or train other regulatory team member(s).
May perform other duties as required or assigned.