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Senior Manager, Quality And Regulatory (Site)
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- Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Leads and manages the site quality and design assurance functions to assure successful new product design transfer and post-market surveillance by collaborating with the Operations, R&D, NPI, Commercial, and Regulatory functions.
- Manages and develops regulatory and clinical affairs to successfully liaison with external regulatory, legal, clinical and physician contacts in support of new products, regulatory strategy, post market surveillance, clinical evaluation, and field actions.
- Responsible for overseeing aspects of regulatory support on new product development, post market surveillance, and regulatory reporting requirements for applicable products.
- Regulatory Affairs Professional Society (RAPS) medical device certification preferred.
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