David Deangelo Email & Phone Number

Minneapolis, Mn, Us

Minneapolis, Mn, Us

Minneapolis, Mn, Us

• Applied project management and knowledge of regulations and external standards to guide and coach new employees in the development of compliant processes and procedures• Analyzed and presented key metrics for complaint closure to senior management• Developed cross-functional collaborative relationships to facilitate engagement, teambuilding, best practice sharing, critical thinking and innovative problem solving.• Managed and drove accountability for process improvements within the Post Market Vigilance group• Ran daily reports to ensure cross functional teams and the Post Market Vigilance group is performing their daily job functions • Performed trending of complaint data and ensure issues are addressed during corrective action board (CAB) meetings• Reviewed root cause analysis for products returns and ensured proper implementation of applicable corrective and preventive actions (CAPAs).• Initiated and prepared Issue Impact Assessment (IIAs) to evaluate the risk and potential effects of product related problems.• Wrote standard responses to Requests for Additional Information(RFAIs) for international governing agencies such as: bfArM, HPRA, AEMPS, and ANSM

Minneapolis, Mn, Us

• Ensured that complaints were maintained and reported from initiation to completion with compliance to the FDA as well as other various international Medical Device Reporting authorities• Worked collaboratively with quality engineering, regulatory affairs, clinical affairs, sales and legal to ensure compliance through timely and accurately managing of MDRs (Medical Device Reporting), MDVs (Medical Device Vigilance) and PMRA’s (Post Market Risk Analysis)• Monitored trending in complaint data to escalate new and emerging issues as necessary• Ensured record documentation is maintained in a constant state of audit readiness per internal policies• Performed follow up activities to obtain additional information on incoming complaints to fulfill Good Faith Requirement (GFE)• Created tracking system for a clinical trial that involved a new stapling product line to monitor safety assessment and adverse events for 200 patients involved

Minneapolis, Mn, Us

• Subjected products in environmental testing to identify their capacity to withstand the rigors of harsh environmental conditions.• Prepared and submitted various pertinent documents including environmental, bioburden, suture dry box, bacterial endotoxin, microbial, total organic carbon testing, and deviation trending issues• Tested for bioburden load prior to sterilization of products• Analyzed and trended for deviations and emerging issues in environmental conditions to escalate to management as necessary• Organized and performed laboratory tests and procedures while maintaining strict alignment with good laboratory practice audits