· Guides or supports the creation and filing of appropriate EU/US submissions to ensure in vitro diagnostic devices are commercially available in Europe and/or U.S. Guides regulatory projects, project schedules, and product introduction process.
· Depending on experience, guides the decision making process on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industry.
· Bachelor’s degree in scientific ...
Seeking experience with IDE's, PMA's and 510k's to ensure regulatory and ISO 13485 comliance and get regulatory approval for medical devices.
Shall oversee management of manage content, assembly, pre-final review, and filing of medical device applications.
Enjoy the career path opportunities that only a growing company can provide while earning a top salary plus bonuses and full company paid benefits – Medical, dental and a vision plan, prescription drug plan, flexible spending account, short and ...
Apr 2 -
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