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Senior Regulatory SpecialistNet-temps - Mansfield, MAProvides medical device Regulatory Affairs technical expertise by participating in the day to day operations of the Department as it relates to preparation of submissions to the FDA and other international agencies on new and modified devices. Assists Department Head in providing direction to departmental mission. Provides technical support to regulatory affairs activities. Works with Department Head to determine effective regulatory pathways for a variety of issues. Participates in ECO process by reviewing ECOs for regulatory filing issues. Participates in multi-departmental teams to implement the regulatory strategies for submissions by determining and obtaining the necessary information required to support submissions. Prepares FDA submissions, including: 510(k)s, IDEs, IDE Supplements,PMAs,...originally from America's Job Exchange - More Tools...
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