• Secure and retain regulatory approvals and registrations for medical devices by formatting, compiling, shipping, archiving, and paying for regulatory submissions and documentation according to policies and procedures within US (FDA) and EU/UKCA notified bodies• Follow QMS and RIM documentation, formatting standards, policies, and standard operating procedure requirements; ensure policies are followed to enter documentation into the official repository - Regulatory Affairs Domain (Calyx… Show more • Secure and retain regulatory approvals and registrations for medical devices by formatting, compiling, shipping, archiving, and paying for regulatory submissions and documentation according to policies and procedures within US (FDA) and EU/UKCA notified bodies• Follow QMS and RIM documentation, formatting standards, policies, and standard operating procedure requirements; ensure policies are followed to enter documentation into the official repository - Regulatory Affairs Domain (Calyx RIM and D2)• Assists in the development, deployment, and maintenance of departmental processes and work instructions to increase overall effectiveness• Creates and provides training to new hires and refresher courses to Regulatory staff• Provide project status updates, create metrics reporting, and input data for tracking measures• Experience with internal/external systems such as Agile MAP, SAP, GTS, Calyx RIM, D2, FDA CDRH Portal, EU regulatory body uploads, and legalization companies• Member of special committees (RAD CAB and Publishing Center of Excellence)• Flexible with changing priorities, initiative-taking, strong work ethic, attention to detail, and works well under pressure in dynamic environments• Lead and initiate special projects (system data cleanups, international registration initiatives)• Advanced knowledge of word processing, spreadsheet, database, and presentation applications (Microsoft Office, Adobe Acrobat) Show less

• Processed necessary documentation for authentications - notarization, apostille, and legalization (Notary Public) to secure and retain international medical device registrations and renewals• Processed requests for Certificate to Foreign Government (CFGs), Certificate of Exportability (CoEs), Certificates of Free Sale (CFSs) for international requests• Worked with various third-party companies for international authentication requests (USL, WCS, CT Corp, MN SoS)• Secure and retain… Show more • Processed necessary documentation for authentications - notarization, apostille, and legalization (Notary Public) to secure and retain international medical device registrations and renewals• Processed requests for Certificate to Foreign Government (CFGs), Certificate of Exportability (CoEs), Certificates of Free Sale (CFSs) for international requests• Worked with various third-party companies for international authentication requests (USL, WCS, CT Corp, MN SoS)• Secure and retain regulatory approvals for medical devices by formatting, compiling, shipping, and archiving regulatory submissions and documentation according to policies and procedures within US (FDA) and EU notified bodies (tech writing and publishing)• Add documentation into the official repository (Regulatory Affairs Domain (RAD) – InSight/D2)• Manage EU certificates in official document repository (RAD)• Add registrations / attach CFNs / create references for US approvals• Use FDA system to pay regulatory fees / use BSI portal to upload submissions• Assists in development and maintenance of departmental processes and work instructions• Creates and presents training to new hires or refresher courses to current staff• Provide project status updates, create metrics reporting, and input data for tracking• Participated in lean sigma/A3 DMAIC trainings and projects • Experience with Agile MAP, SAP, GTS, Documentum• Lead and initiate special projects gathering information from various team and presenting results and implementations• Advanced knowledge of Adobe Acrobat and Microsoft Office programs Show less

• Processed necessary documentation for authentications - notarization, apostille, and legalization (Notary Public) to secure and retain international medical device registrations and renewals• Processed requests for Certificate to Foreign Government (CFGs), Certificate of Exportability (CoEs), Certificates of Free Sale (CFSs) for international requests• Worked with various third-party companies for international authentication requests (USL, WCS, CT Corp, MN SoS)• Secure and retain… Show more • Processed necessary documentation for authentications - notarization, apostille, and legalization (Notary Public) to secure and retain international medical device registrations and renewals• Processed requests for Certificate to Foreign Government (CFGs), Certificate of Exportability (CoEs), Certificates of Free Sale (CFSs) for international requests• Worked with various third-party companies for international authentication requests (USL, WCS, CT Corp, MN SoS)• Secure and retain regulatory approvals for medical devices by formatting, compiling, shipping, and archiving regulatory submissions and documentation according to policies and procedures within US (FDA) and EU notified bodies (tech writing and publishing)• Add documentation into the official repository (Regulatory Affairs Domain (RAD) – InSight/D2)• Manage EU certificates in official document repository (RAD)• Add registrations / attach CFNs / create references for US approvals• Use FDA system to pay regulatory fees / use BSI portal to upload submissions• Assists in development and maintenance of departmental processes and work instructions• Creates and presents training to new hires or refresher courses to current staff• Provide project status updates, create metrics reporting, and input data for tracking• Participated in lean sigma/A3 DMAIC trainings and projects • Experience with Agile MAP, SAP, GTS, Documentum• Lead and initiate special projects gathering information from various team and presenting results and implementations• Advanced knowledge of Adobe Acrobat and Microsoft Office programs Show less

• Typed, proofed, formatted, and assembled complex financial reports for governmental / commercial entities• Assembled tax returns for individuals and businesses• Scanned tax documents• Participated as a member of the marketing committee by attending meetings, creating new branding documents, and updating the website• Created and submitted proposals to attract new firm revenue• Provided backup support to front desk

• Typed, formatted, and processed complex governmental financial reports• Aided with SharePoint issues and updated pages as necessary• Prepared templates, engagement letters, representation letters and other correspondence• Restructured and updated administrative assistant process manualExperience (continued)• Created and submitted proposals to attract new firm revenue• Created and formatted reports illustrating company goals and metrics• Scheduled and sent out… Show more • Typed, formatted, and processed complex governmental financial reports• Aided with SharePoint issues and updated pages as necessary• Prepared templates, engagement letters, representation letters and other correspondence• Restructured and updated administrative assistant process manualExperience (continued)• Created and submitted proposals to attract new firm revenue• Created and formatted reports illustrating company goals and metrics• Scheduled and sent out information regarding preliminary work and fieldwork for audits• Setup new clients and provided ongoing communication• Organized and managed a project load of 100 audit reports per year via a complex project tracking form• Scheduled and initiated video conference calls utilizing screen share technology Show less

• Provided high-level support to the Senior Vice President, two Vice Presidents and multiple directors maintaining a high level of confidentiality • Managed numerous calendars, scheduled meetings, rearranged calendars• Prepared agendas, reserved meeting rooms, made meeting arrangements, and took meetings minutes• Made travel arrangements• Assisted with onboarding and offboarding of associates• Performed general administrative duties including maintaining office files… Show more • Provided high-level support to the Senior Vice President, two Vice Presidents and multiple directors maintaining a high level of confidentiality • Managed numerous calendars, scheduled meetings, rearranged calendars• Prepared agendas, reserved meeting rooms, made meeting arrangements, and took meetings minutes• Made travel arrangements• Assisted with onboarding and offboarding of associates• Performed general administrative duties including maintaining office files, photocopying, sorting, and routing incoming mail, ordered office supplies, answered/routed telephone calls, and created expense reports Show less

• Provided high-level support to General Manager, the direct reports, and Human Resources• Pulled reporting data and updated weekly labor and financial reports• Managed the employee communication system• Created PowerPoint presentations for the communication system and meetings• Coordinated events (holiday luncheons, retirements) and campus tours• Assisted in calendar management and scheduled meetings• Performed general administrative duties including maintaining office… Show more • Provided high-level support to General Manager, the direct reports, and Human Resources• Pulled reporting data and updated weekly labor and financial reports• Managed the employee communication system• Created PowerPoint presentations for the communication system and meetings• Coordinated events (holiday luncheons, retirements) and campus tours• Assisted in calendar management and scheduled meetings• Performed general administrative duties including maintaining office files, photocopying, sorting, and routing incoming mail, ordering warehouse/office supplies, answering/routing telephone calls, maintaining seniority rosters, employee files, phone and department directories; and managing attendance and vacation for all exempt employees Show less

• Used Microsoft Excel on a daily basis to create complex spreadsheets• Used many internal based software for daily duties• Performed general administrative duties including maintaining office files, photocopying, sorting and routing incoming mail, answering/routing telephone calls

• Attended to potential clients in reception area• Typed up client profile information and revised for spelling and grammar• Entered client selection data into database• Assisted client in creating profile video• Trained clients in how to navigate company website• Received incoming customer and client calls• Looked up activity in database for existing clients• Assisted in “personal shopping” on database for clients• Handled escalated client issues

• Provided direct support to Director (1) and Event Marketing Representatives (3)• Processed accounts receivable, accounts payable, check requests, and expense reports• Coordinated contracts• Prepared paperwork and packed for external events; • Functioned as volunteer coordinator and trainer• General duties included: wrote press releases, scheduled travel arrangements, managed and ordered inventory, and managed calendars, prepared meeting locations, ordered catering, set-up… Show more • Provided direct support to Director (1) and Event Marketing Representatives (3)• Processed accounts receivable, accounts payable, check requests, and expense reports• Coordinated contracts• Prepared paperwork and packed for external events; • Functioned as volunteer coordinator and trainer• General duties included: wrote press releases, scheduled travel arrangements, managed and ordered inventory, and managed calendars, prepared meeting locations, ordered catering, set-up conference and video conference calls, maintained and updated all databases, received/sorted/distributed mail Show less