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Sr. Manager, Regulatory Affairs, Akura Medical
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- akuramed.com. ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
- Description The Sr. Manager, Regulatory Affairs champions the company's overall regulatory submission and approval efforts, ensures regulatory compliance within all markets in which company products are marketed.
- Interacts with the FDA (and international regulatory agencies) on a proactive, independent, and frequent basis.
- Reviews product development, bench testing, animal testing, quality assurance, manufacturing, quality system, marketing, and clinical research study reports and other regulatory documents.
- Oversees the management of MDR/Vigilance reporting of company products.
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