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Regulatory Affairs Specialist

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Compunnel

2024-09-19 16:48:17

Job location Chaska, Minnesota, United States

Job type: fulltime

Job industry: Government & Defence

Job description

Responsibilities:

The Regulatory Affairs Specialist II will support the IA business unit in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepares regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Respond to regulatory agency inquiries. Knowledge of product history, profile, specifications, standards, safety issues, precedents and approval. Job Duties: Investigate regulatory history of similar products to assess approval implications. Meet and follow policies and procedures to complete milestones. Communicate with internal technical (engineers/scientists) and regulatory personnel. Interpret and evaluate data. Write and edit technical documents. Prepare and submit IVDR documentation. Prepare and submit Global registration documentation. Electronic submission process, types and requirements (CLARA). Monitor applications under regulatory review. Maintain regulatory files. Import/export requirements. Update and maintain paper/ electronic document archival systems. Determine product regulatory path or class. Evaluate design changes for regulatory filing strategies. Assess regulatory impact and risk. Develops plan for timely renewal registrations to ensure continued product supply. Communicate closely with the Headquarters on the needs and problems of registration documentation and registration test.

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