Bethany Nimmer

Business Development

• Identify, evaluate, and prioritize new business opportunities to align with organizational goals
• Develop and maintain strategic partnerships with key stakeholders, clients, and industry leaders
• Collaborate with cross-functional teams to design and implement business strategies
• Create detailed proposals, presentations, and business plans for potential partners and projects
• Conduct competitive market research and identify trends to position the organization effectively

Leadership:

• Coach, mentor, train existing employees and new hires on company values and how to effectively implement new communication strategies
• Resolve team conflicts
• Resolve client concerns

Communication:

• Served as a trusted advisor to senior management on growth strategies and analytic
• Lead discussions and workshops with internal teams and external partners to align goals and deliverables.
• Mentored team members on analytics tools, methods, and best practices
• Presented findings and strategic recommendations to stakeholders clearly and effectively

Company Overview

Abbott Medical is global leader creating breakthrough products in diagnostics, medical devices, nutrition and branded generic pharmaceuticals. Founded in1888, headquarters located in Chicago Illinois

Data Management

• Identify, analyze and report/resolve data issues, related to uniqueness, integrity, accuracy, consistency and completeness
• Participate in system user acceptance testing and assist in developing test scripts/scenarios as requested
• Facilitate the rollout of tools and systems to additional sites, including training and/or maintenance
• Proficient use of SAP and WindChill PLM for product life cycle data
• Support for Quality Management Systems (QMS), and Environmental Management Systems (EMS)
• GTIN Subject matter expert and main point of contact within UDI division
• Compile and deliver GTIN related systems training to supporting divisions

Compliance

• Comply with U.S Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
• Support Data Governance by ensuring compliance with the enterprise data governance standards, processes, procedures, through joint leadership in the Project and IT governance processes
• Develop and maintain training materials and conduct training to associates when requested
• Identify any data integrity issues and apply solutions within SAP, Infomatica, and WindChill
• Collaborating in writing new detailed standard operating processes and implementing changes to existing documents

Internal and External Customer Service

• Work directly with business users to support existing applications and resolve business problems
• Identify, evaluate and implement improvements to applications
• Work closely with corporate business teams to ensure all aspects of solutions are delivered consistently
• Work closely with corporate business teams to supply requests for information as needed

• Experience working in quality systems where regulations and guidelines are followed, including21 CFR Part820,21 CFR Part11, MDSAP, EU MDR, EU MDD, ISO13485
• Clear understanding on the new EU Medical Device Regulation (EU MDR), with methodical remediation process to ensure client products retain CE Mark
• Responsible for compiling and submitting all FDA Annual Performance Reporting based on specific PMA
• Prepare Custom Device reporting
• Global Regulatory Assessment Report for global countries EA (European) and LATAM (Latin America)
• POC for newly implemented CRM Systems and provide training on new systems processes
• Participated in cross-functional product development and manufacturing project teams
• Provided guidance to project team on content for the PMA submissions for assigned sections
• Knowledge regarding EU MDR (Medical Device Record) requirements
• Hands-on knowledge and experience in global post market surveillance (FDA MDR and OUS vigilance reporting)
• Reviewed product and manufacturing changes for compliance with applicable regulations (engineering change orders)
• Responsibility included but not limited to the following PMA sections; device manufacturing (quality systems and software), animal studies summary, proposed labeling, referenced performance standard/voluntary standard, environmental assessment under21 CFR25.20(n) ((d)(l) or (ii), pediatric use – per515A(a)(2) of the FD&C Act, statements/certifications/declarations of conformity
• Responsible for collecting metrics evaluating the effectiveness of regulatory and biocompatibility related operational processes and business development goals and provides updates to the management team
• Collaborate with in country representative to prepare and submit Health Canada Annual Report
• Preparing high quality presentation/training materials to meet project objectives for internal and external communication
• Understanding of GTS licensing and usage of differentiating shipping licensing
• Identify areas of need in business practices and reporting improvement; work with cross functional departments to identify and implement solutions
• Identify areas of non-compliance and facilitate new compliance system implementation
• Collaborated with IT team in the creation and testing of a global regulatory submission and approval database for quick and effective product release and management via GTS
• Collaborated with functional groups to develop tools and data to support regulatory and production activities
• Collaborated with IT while Assisting in migration of Team Center to WindChill
• SME, POC, and Trainer on new IT PLM System for regulatory approvals and submission recorders

Company Overview

St. Jude Medical Inc (Now Abbott Medical), a global leader in cardiac and neurological device technology, with a product portfolio built through internal development and strategic acquisitions. Founded in1976 and headquartered in St.

Paul, Minnesota, we have four major focus areas: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.

• Monitor all sales professional’s activity to ensure compliance with the Sunshine act
• Review, analyze, and decipher compliance of active participants
• Develop, deliver and maintain training materials to sales team as needed