Location: Malvern, Pennsylvania 19355
Duration: 5-6 Months
Participates in writing and filing appropriate FDA Post Market submissions (e.g. MDRs and Recalls and Corrections). Prepares, reports, and or maintains company filings with FDA so that products may be imported into the US. Assists with filing of complaints. Participates in regulatory projects and processes. Participates in decision making on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industry. Performs training of quality counterpart in Germany on FDA requirements.