Exec. Asst. To Chief Civil Engineer Resume
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Weymouth, MA
SUMMARY
- Prepare International Re - Registration Document Submissions to Regulatory Affiliates in 140+ Countries seeking medical device product licensing (Latin America, Asia Pacific, Middle East, EU, Australia, USA & Puerto Rico.
- Notarizing country-specific documentation; Legalization services for Apostille or Consular Stamp.
- Maintain product code listings, DOC, DEC, CFG, CFS, IFU, POA, FQA, Physical manufacturer ISO, Legal manufacturer ISO, CE Certificates, Marketing Brochures, Labels, Quality Manuals, Corrective Action Reports, PMS Reports, Clinical Evaluation Reports, Certificates of Analysis, Letters of Declaration, Risk Management Reports, etc.
- Preparation of Regulatory Intelligence Reports and Final Reporting to upper management.
- Utilizing FDA database for 510(k) info., Establishment Registrations & Medical Device Listings.
- Worldwide Labeling Change Order reviews and approvals.
- Support to internal Operating Companies: DePuy Spine, Inc., DePuy Orthopaedics & Joint Reconstruction, DePuy Mitek Sports Medicine, Codman & Shurtleff Neuroscience and Neurovascular medical devices, DePuy France Implants & Instruments.
- Conference Calls, On-site Meetings with members of Regulatory Operating Companies, Supply Chain, Worldwide Labeling, Demand Planning, Marketing & Corporate Event Planning.
- Cross-Trained to assist in code validation process of International Regulatory Approvals Database (RAD) and its Team functions.
- Windows 10 -- Outlook Exchange & Calendar Management, Excel, PowerPoint, SharePoint, Adaptiv, Compliance Wire, Summit.
PROFESSIONAL EXPERIENCE
Confidential,Weymouth, MA
Exec. Asst. to Chief Civil Engineer
Responsibilities:
- Proposal & Report Editing, Professional Engineering Registrations and Renewals, Organized Lunch & Learn Presentations, PowerPoint Project Sheets for Proposal Submissions, and Project Manuals.
- Dept. of Environmental Protection Forms & Reports, Central Register & Newspaper Advertising when projects went out to Bid. Projects with the Massachusetts Department Of Environmental Protection, Massachusetts Department Of Transportation, Massachusetts Aviation Commission, & Massachusetts Aeronautical Commission.
- Compiled research & filing of legal matters for Third Party Reviews, Expert Witness Testimonies and Due Diligence Reports.
- Prepared Bid Packages from project inception to final project close-out, Conference & Seminar Registrations, 24x36 Plotter/CAD Plans client delivery and Monthly Expense Reports & Aged Accounts Receivables Tracking.
- Civil Project Manager Requests and preparation of On-Site Field Meeting Notes.
Confidential
Sr. Exec. Asst. to Managing Partner
Responsibilities:
- Proficiency in MSOffice, Word, Outlook, Explorer, Adobe InDesign-CS 3.0 Version, PowerPoint, Adobe Professional Acrobat 6.0 (create PDF files), Excel Spreadsheets, Document Scanning, Deltek-CRM Lead Tracking Software.
- Processed Professional License Applications & Renewals, Conference & Hotel Registrations, Client-Specific Proposal Deadline Submittals, Monthly Expense Reports, Marketing Materials Proposals & Revisions. International & National Travel Arrangements, Coordinated Client “Lunch & Learn” Seminars, Participated in Video-Conference Marketing Meetings with Branch Office Representatives, and assisted in all aspects of daily administrative functions.
Confidential, Quincy, MA
Office Mgr. & Asst
Responsibilities:
- Liaison between clients, ad executives, & graphic artists to edit text copy, layouts and distribution deadline submissions. Distributed press releases to local & national print, radio & television media. Assisted desktop publishing design & editing of newsletters & advertisements appearing in daily/weekly/monthly deadline publications.
- Office supply orders and assisted in large volume mass mailing lists (i.e., 3000+ addresses) for established client distribution (i.e., Quincy Business News and Masonic Lodge of Pennsylvania).
- Initial contact with vendors for newspaper & magazine advertising space.
Confidential, Boston, MA
Sr. Associate
Responsibilities:
- Responsible for accurate lead tracking databases of residential & corporate group clients. Detailed coordination of marketing materials for promotional sales quota meetings. Process Life insurance applications from sales representatives. Scheduled in-house meetings between Sr. Mgmt. and sales representatives for weekly sales & service overviews. Development of company newsletter with monthly editing.
