Regulatory Business Systems Analyst

2 semanas atrás

Lisboa, Portugal Advanced Sterilization Products Tempo inteiro

Strategic cross-functional team member focused on supporting the company’s commitment and on-going investment to mature systems and digital capabilities. Project management for the selection, planning, validation, configuration, implementation, and daily management of software related to regulatory and labeling processes.

Experience with modern regulatory systems, current footprint includes, BarTender, SAP-EHS, and Veeva.

Subject matter expert for all regulatory and labeling software programs. Interface with regulatory, labeling, product stewardship, master data and other teams to develop strategies for future improvements and cost reduction programs.

Implement customer driven improvements by developing user requirements based on VOC to understand the user experience and unmet needs.

Interact with ASP and Fortive IT to build and maintain data links between regulatory and labeling software and Enterprise software utilized by the organization. Maintain a strategic view of software systems related to regulatory and labeling, identify opportunities to expand integration with company data sources.

Deliver results by providing incident response with high internal and external customer satisfaction. Oversee the maintenance and compliance of regulatory software systems. Execute tactical plans to expand the usage of regulatory and labeling software with internal and external partners.

Partner with Global IT and external service providers to manage and implement enhancements and improvements. Software administration, implementation of technology updates, maintenance of the APIs with Enterprise systems and capacity management reporting. Document the integration of each software with the Enterprise systems as a reference for future upgrades or maintenance.

**Responsibilities**:
Remain current on state-of-the-art development platforms, tools, and techniques. Recommend strategic upgrades for existing systems and programs. Maintain product roadmap.
Own system requirements using standard tools such as, diagrams, flowcharts and models that illustrate process flows and assist with the implementation of upgrades or the selection of new software.
Subject matter expert for all regulatory and software programs, including BarTender, SAP-EHS, and Veeva. Key support contact for software systems.
Support software users, including account management for internal and external resources, training, and technical support. Lead the roll out and adoption of enterprise labeling platform to internal and external partners. Expand the use of labeling software to all suppliers.
Mentor internal team members to support knowledge development through coaching, training, and collaborative feedback.
Ensure all quality and regulatory requirements are met for the validation, installation, and maintenance of software.
Identify software incidents and customer concerns, resolve customer issues expediently and accurately within standard lead times. Ensure continued functionality of software during maintenance and testing.
Coordination with the labeling team, and other groups as needed, to establish minimum standards for outputs such as printers and print materials. Maintain standard requirements for printing and print quality for internal manufacturing and external suppliers.
Facilitate cross-functional group that reviews labeling and quality requirements and identify ASP standards. Improve labeling cycle time. Maintain data structure, edits, and controls to ensure data accuracy.
Facilitate and manage User Acceptance Testing.
Create and manage SDLC project deliverables (e.g., test cases, user requirements, specification, design documentation). Utilize various software development lifecycle tools (waterfall, agile, etc.).

Education

Bachelor’s Degree

Years of Related Experience

**Preferred area of study**: Computer Science, Engineering, Mathematics, or related field
10-15 years Business Systems Analyst experience
3-5 years database experience SQL (e.g., SQL, Oracle)
Medical device labeling software experience, Bartender or Robar preferred

Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

Ability to think strategically and undertake contingency planning
Self-starter, who is proactive, motivates and has tact, diplomacy, and project management skills, with a flexible and positive approach.
Strong interpersonal skills for cultivating effective collaboration between team members.
High degree of problem-solving ability, with an understanding of objectives and processes across multi-disciplinary functions.
Able to successfully execute to deadlines and prioritize conflicting demands.
Strong attention to detail.
Must be able to work effectively with little or no direction, and build collaborative relationships with management, partners, and peers from diverse backgrounds.
To be successful, this role requires effective written and oral communication, with the ability to explain technical concepts to inexperienced users.
Demonstrat

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