Regulatory Affairs Specialist

DIANE I. BERANIA

*** ***** & Ready Road San Jose CA 95133

408-***-**** mobile

Email: *********@*****.***

REGULATORY AFFAIRS SPECIALIST

Highly motivated, results-driven Regulatory Affairs Specialist specializing in Medical Devices within the healthcare industry.

A visionary experienced in supporting regulatory affairs, medical devices, aesthetics working with experienced professionals such as surgeon’s, physicians and clinical professionals in oncology, cardiovascular, plastic surgery and aesthetics.

COMPETIENCIES

Regulatory Affairs

Medical Device Sales

Account Management

Quality Assurance

Strategic Sales

Product Development

Project Management

Manufacturing Experience

Revenue Assurance

Regulatory Affairs

Clinical Operations

Clinical Marketing

Product Educator

Leadership Training

Product Training

Safety/Health Educator

Trainer/Coach

Sales Trainer

ASCEND PEAK PERFORMANCE– San Jose, California May 2005 – March 2011

Senior Regional Account Executive

Senior Regional Account Executive to prospect, drive new business and provide support to medical device and biotechnology accounts within the San Francisco Bay Area, CA. Responsibilities include marketing and preparing sales proposals, consulting agreements, contracts and financial agreements related to the medical device industry. Train and shadow junior sales representatives within the region/territory.

Senior Account Executive with Meridian Medical; exclusive territory in North America supporting medical device manufacturer/distributor in Canadian and European markets in clinical cardiology digital pulse wave analyzer and cold laser medical device/aesthetics. Maintained excellent track record generating new business/accounts in the Northern CA region. Hit all targets consistently 90%. Doubled target expectations.

Contracted as Medical Device Account Executive with My Choice Medical; exclusive Northern CA Region supporting 8 plastic surgeons throughout the South Bay Area of California. Clinical Assistant and office support. Hit all sales targets consistently, contract management, financing, generated leads prospects. 90% closure rate.

Ensured compliance with all applicable regulatory requirements while on assignment with Medical Device companies according to FDA and classification designations (ISO 13485).

Communicated product and device requirements within the clinical and office setting for applicable uses (Class II and III devices). Familiar with device and design specifications.

Developed strategic sales and marketing plans, drafted proposals for new business prospects, prepared contracts, and assisted accounts with financing process/capital equipment.

Experienced in cold calling, B2B sales strategies and focusing on customer retention in the pipeline.

Senior Contract Manager for web development company utilizing inside and outside sales methodologies, extensive project management, expert in email marketing, developing social media campaigns, webinars, and growing customer base organically. Experienced in writing and developing case studies, creating a strong portfolio for marketing and distribution.

LASTING IMAGES DAY SPA – Elk Grove, California FEBRUARY 2002 – MAY 2005

Owner/Business Development Manager

Responsible for managing all aspects of business development for leading aesthetic day spa. Self-managed, planning, build-out & development one year prior to Grand Opening.

Created marketing strategies to promote new sales growth and visibly for the business. Utilized all social media outlets for a surge in new accounts and expand branding awareness.

Responsible for managing and supervising a staff of eight contractors.

Managed aesthetic and retail product lines for sales, distribution and training.

Responsible for all sales invoicing and end of day close.

Experienced with maintaining budgets and quarterly tax preparation.

Responsible for screening, hiring new and temporary personnel.

Prepared competitive data analysis and market research reports.

Supported local charities for disadvantaged and cancer/leukemia organizations.

INTEL CORPORATION – Folsom, California JANUARY 1995 – FEBRUARY 2002

Chipset Business Analyst (Mobile, Desktop, Workstation Chipset Platforms)

Business Analyst for chipset product lines (high volume manufacturing , mobile, desktop and workstation server) utilizing SAP R/3, Unix, advanced excel performing data analysis and supply chain management for worldwide portfolio of major Computer Manufacturer OEMs.

Responsible approximately $55M high volume manufacturing chipset product lines worldwide including Japan, Europe and Asia. Required advanced SAP data analysis, direct procurement, manufacturing projections build out, cost modeling, customer supply/demand analysis to support portfolio of major OEMs such as Dell, Hewlett Packard, IBM, Toshiba worldwide.

Lead analyst on various task forces responsible for project phases utilizing SDLC methods including, project initiation, planning, requirements definition and design; execution of development, QA, UAT and market simulation testing; responsible for project performance monitoring, manage project change control, program management.

Lead, managed project risk team provided GAP analysis plans. Reduced overall hold-over (i.e. ending on hand aged inventory) by 80%.

Served as liaison between manufacturing, engineering, product marketing and R&D teams regarding product quality issues and new product releases/price breaks.

Collaborated with SAP master team through conversion upgrade and beta testing.

Prepared project documents including detailed project plans, work breakdown instructions, roles and responsibility matrices, project schedules, risk registers, issue logs and project status reports.

Project lead for Revenue Assurance project reducing costs/inventory by $15M in warehouses worldwide.

Software, Project Management (CR) Applications/Operating Systems

MS Office, MS Project, Pro Workflow (Project Management), MS SharePoint 2.0, Connect Wise, QuickBooks, SAP R/3, Visio 2003, SQL, Sales Force, PeopleSoft, Crystal Reports.

Windows NT/XP/Vista

SDLC, HIPPA, OSHA, 510k, PMAs, 1348, QSR, FDA, 820 CRFs

EDUCATION

UNIVERSITY OF SANTA CLARA

Bachelor of Science in Business Administration

RAPS UNIVERSITY

Regulatory Affairs – Medical Devices Certified

Medical Device Regulations, Clinical Trials, Ethics, Global Regulatory Strategy/Devices, Project Management for Regulatory Affairs, Role of the Regulatory Affairs Professional, Good Manufacturing Products (GMPs), Medical Devices- Definition and Lifecycle

Intermediate Medical Writing - Contracts, Proposals, FDA Compliance & Filings

ASLAN INSTITUTE

Medical Device Field Sales Training (Inside/Outside)

PROFESSIONAL MEMBERSHIP/ASSOCIATIONS

Active Silicon Valley American Marketing Association Member & Volunteer

Active RAPS Member (Regulatory Affairs Professional Society)

PMI Project Management Institute Member

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