「regulatory-affairs」の検索結果

Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence.

日本語の概要は準備中です。原文の説明を表示しています。

Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.

日本語の概要は準備中です。原文の説明を表示しています。

Use when a task needs the judgment of a biomedical/bioengineering engineer — running a design control phase (inputs, outputs, verification, validation) for a medical device, scoring a Design FMEA and deciding whether a failure mode needs mitigation, planning a human factors/usability validation study, building a design traceability matrix, or writing a design verification or risk-mitigation report. Distinct from a regulatory-affairs-specialist (owns the submission/clearance process, not the engineering itself) and from a clinical-data-manager/biostatistician (trial data and analysis, not device design).

日本語の概要は準備中です。原文の説明を表示しています。