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

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.

- 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.

- 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.