Meg D. Email & Phone Number

Eden Prairie, Mn, Us

- Regulatory lead for a new product development team- Authored Q-submission and 510(k)- Regulatory lead for a syringe-based contrast injector for use in CT imaging. Responsible for assessing impact of changes to items such as software, hardware and disposable syringe kits.

Minneapolis, Mn, Us

Peripheral Vascular Health - PVH- Core Team regulatory lead for MDR transition team - Develop and support business unit strategy for transitioning certification of 25+ class III, IIb and IIa invasive devices- Regulatory lead for product development team of an active device containing firmware from concept to design validation phase - Authored and negotiated FDA pre-submission and IDE application- Manage project timeline and inputs for MDR application for a class III transient device and transfer of notified body for business unit's product portfolio- Author and communicate with regulators on submissions including EU MDD and MDR reviews as well as PMA 30-Day Notices and Annual Reports- Assess changes to the design, manufacturing, labeling, or sterilization of new and legacy products in order to determine impact to related submissions or registrations- Provide cross-functional input and review of documents such as plans and reports for Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), Clinical Evaluation (CEP, CER, & SSCP) and Standard Operating Procedures (SOP)- Provide front and back room support to internal and external audits to requirements of MDD, MDR and ISO 13485 using MDSAP methodology- Conduct internal audits of other Medtronic facilities as Regulatory Subject Matter Expert- Review advertising and promotional materials- Regulatory representative on CAPA board

Humlebæk, Denmark, Dk

• Authored submissions to FDA including abbreviated and traditional 510(k)s, PMA Supplements and Interim Postmarket Surveillance (522) Study reports• Authored new STEDs, device amendments and cosmetic notifications to Health Canada• Evaluated Advertising and Promotional materials (print, tv, online) on medical devices and cosmetics• Assessed complaints of implanted devices and reported to FDA and Health Canada and participated in crossfunctional review of complaints as part of launch surveillance• Complete labelling review for medical devices• Drafted Standard Operating Procedures for use in US and Canada

Humlebæk, Denmark, Dk

• Managed 20+ study sites across 4 protocols (IDE and postmarket) from site activiation through closeout, including conducting periodic monitoring visits, oversight of data collection and adverse event reporting, and maintaining IRB approval• Drafted Monitoring Plans, Data Management Plans, and CERs• Create and presented training to Coloplast and research site staff• Participated in cross-functional review of complaints as part of launch surveillance• Prepared clinical content for periodic FDA IDE reports• Forecasted and managed 4 study budgets

Humlebæk, Denmark, Dk

- Monitored study sites' adherence to study protocols through on-site visits and EDC review- Assisted with site identification, qualification, initiation, training, monitoring, and close-out activities- Conducted monthly literature searches and sorted for inclusion in reports- Aided in production of CRFs, CERs, data reports and site training- Tracked study budgets and department expenses

Ba, French Studies

Education record

Nursing Assistant Certification