Sandra Nosich Email & Phone Number

Chelmsford, Massachusetts, Us

Charlotte, Nc, Us

A medical devices & equipment manufacturing company with 27 employees specializing in predictive glycemic management software with approximately $11.1 M in annual revenue.Responsible for supporting the Quality/Regulatory department as required in all aspects of quality control, quality assurance, and regulatory compliance activities. Supported the required reporting and investigation of all medical device complaint-related procedures, in accordance with applicable laws and regulations. Additional responsibilities include SalesForce.com, Administration functions, and assisting with Project Management on an as-needed basis.• Facilitated the overhaul of an underdeveloped and neglected Compliance System by reviewing and rewriting Policy & Procedures and other documentation as required. • Handled all Complaints, and managed CAPA, Internal Audits, and Training processes.• Managed and Tracked the software upgrades for 2 Class 2 Device Recalls

Charlotte, Nc, Us

Oversaw all internal projects (Product, R&D, Complaint Management, Education, Professional Services) to ensure on-time delivery of future software deliverables and facilitate and drive changes for efficiency to deliver significant functional product development projects. As well as leading, coaching, and driving groups and individuals for personal development and department/company objectives fulfillment.• Obtained Agile Leader Certification• Improved internal awareness of process breakdowns for improved software delivery

Charlotte, Nc, Us

Managed up to 30 client projects at a time, working closely with client representatives across all hierarchies from Chief Medical Officers to front-line nurse end-users. Provided subject matter expertise and guidance to clients on internal processes, identifying solutions to enhance efficiency by educating clients on maximizing the effectiveness of devices and software.• Effectively managed accounts and provided clinical product advice to improve and drive sales and revenue growth, collaborating closely with clients to assess needs. • Worked with clients throughout the sales process, from pre-sales technical and clinical consulting to implementation planning, and managing clinical discussions. • Provided ongoing support for products and developed strong relations ensuring client satisfaction.• Worked directly with client teams in performing gap analysis, managing policy assessments, and drafting comprehensive workflows for project development. • Developed client-specific parameters and parameter interactions, and optimized end-user experience. • Discussed HL7 messaging standards with clients and reviewed their processes and workflows to ensure best practices and proper clinical documentation. • Performed patient scenario testing and ensured updates were integrated appropriately.• Directed cross-functional teams incorporating product, professional services, clinical, and sales. • Managed a team of clinician direct reports, leveraging their practical expertise to provide clients with comprehensive insight.• Coordinated with product and IT on enhancements, database impacts, and performing SQL queries to retrieve, compile and analyze data.• Implemented process improvements with a performance-oriented approach, showcasing strong interpersonal, organizational, and time management skills.• Implemented project management methodology for software project installations.• Successfully decreased installation time and improved customer satisfaction.

FUJIFILM Medical Systems USA Inc (Fujifilm Medical), a subsidiary of FUJIFILM Holdings America Corp, is a provider of medical imaging and information products and technologies for the diagnostic imaging markets.FMIS liaison for Marketing and Sales development, support, and training of international FUJIFILM Companies and Distributors for all MI product lines (CR/DR/MAMMO/3D/CV/PACS/VNA). Responsible for bringing customer-centric thinking into the R&D design process, and ensure developed products solve real clinical needs and represent a meaningful business opportunity, and developing impactful branding, positioning, and claims, to support successful worldwide product launches while working closely with regional teams. • Supported cross-platform activities that reach beyond a singular device platform to strategically impact innovation and marketing activities.• Trained international personnel in Project Management techniques and lead large enterprise projects. • CAPA representative for all international support issues. Additionally, served as the SF.com administrator for the Partner Community.• Spoke at International Conferences introducing newly released diagnostic software.• Developed, maintained, and led training around the world.

• FMSU liaison for Marketing/Sales and Clinical Training. • Supported development of the international Fujifilm Companies and Distributors.• Pioneer member of the international team to develop strategic business development throughout the world.

Pmp® Number: 2172366, Project Management

Master Certificate In Applied Project Management - Id Number: 45291595, Project Management

Master Of Arts - Ma, Clinical Psychology

Bachelor Of Arts - Ba, Psychology