Danielle Rainey Email & Phone Number

Greater San Diego Area

• Preparing draft and final versions of regulatory submissions to U.S. and international regulatory agencies using knowledge or experience in biotech regulations for substances used in food and industrial processes• Participating on product development teams as assigned• Providing support to Process Development, Manufacturing, QA/QC, and Business Development using knowledge of biotech regulations and food cGMP’s• Summarizing technical and safety information in final study reports for regulatory submissions• Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions•Assisting in coordinating and maintaining a document control system for pertinent regulatory documents

•Responsible for company and product registration, certification and licensure such as FDA, USDA, ISO, CLIA, CDC, state, city and county licenses and permits. •Compose department SOPs and laboratory Biosafety Plans for Therapeutic Clean Rooms according to the CDC’s BMBL•Responsible for submitting the EU Regulation 142/2011 Pre-Inspection Packet to the USDA•Assist and provide support in the preparation and execution of ISO, FDA, CDC internal and external audits•Coordinates Lookback Market Notifications process concerning imported blood products•Assists with WIRB submissions and manages all WIRB correspondence•Supports Director of Quality/Regulatory Affairs •Responsible for preparing applicable regulatory forms and paperwork to European, Mexican, Taiwanese and Canadian regulatory agencies as requested•Assists with department’s validation protocol restructuring initiative•Comfortable navigating regulatory governed websites

Biologics:- Coordinated and assisted with the preparation of regulatory submissions such as PMAs, IDEs, INDs and 510(k)s for FDA Class I, II, and III spinal, dental, and biologic medical device products.- Coordinated routing and tracking of promotional material, sales support and training literature. Responsible for tracking and communicating monthly metric report.- Provided exemplary administrative assistance to Sr. level regulatory staff such as: drafting submission cover letters, answering phones, copying, preparing shipping labels, scheduling meetings and managing calendars.- Directly and indirectly interacted with various FDA professionals. - Coordinated and scheduled travel arrangements for regulatory management and interviewing applicants- Comfortable navigating the FDA; to search the regulations (800s series of CFR; CFR part 820 for design control for devices) HR Cross-functional Responsibilities: -Coordinated multiple Regulatory Talent Acquisition Days.-Coordinated candidate air travel, ground transportation, hotel accommodations, reserved conference rooms and created interview meeting agendas for over twenty (20) candidates.

- Assisted manager and curator of the museum with projects such as museum beautification and TSRH 20th Celebration.- Provided administrative support to museum staff such as answering phones, scheduling meetings and museum tours for executive staff and surgeons, events, processing check requests, photocopying/scanning and ordering office supplies.

- Created and updated physician databases using information gathered from Siebel, MySpine Tools and other internal databases.- Researched physician information using internet resources and telephone inquiries.

- Regularly scheduled external recruiting to attract top talent by working with Store Managers to develop hiring strategy, scheduled group interview process, and managed associate training and orientation curriculum. - Provided feedback to management regarding the performance and development of team members by utilizing computerized tracking tools and programs. - Set up and maintained all new hire paperwork by adhering to all state and federal regulatory employment requirements inclusive of I-9 compliance, work permits and payroll practices. - Supervised team of 16-20 people daily.

- Assisted in developing documentation for instructional, descriptive, reference, and/or informational purposes to meet FDA regulations for OTC pharmaceutical products. - Specialized in editing and writing standard operating procedures, clinical study protocols, laboratory procedure manuals, formula labeling and other related documents.