Researches and determines requiremants (local, national, international) and options for regulatory submissions, approval pathways and compliance activities. * Monitor and evaluate the regulatory environment and provide creative and innovative internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance. * Identifies the need for new regulatory procedures and SOPs and assures that departmental SOPs are developed to ensure regulatory compliance and participate in development and implementation. * Notifies organization and as necessary Regulatory Authorities as required regarding product safety issues to ensure compliance with local, regional, and global regulations. * Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971, …
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