Sr. IT Business Relationship Manager

Cloudious•Alameda, CA

4d•Onsite

About The Position

The Sr. IT Business Relationship Manager will be responsible for working closely with Quality and Regulatory business partners to develop and maintain comprehensive Quality and Regulatory IT road maps for Complaints Systems. This role is responsible for IT Capital and Expense financial projections, planning, and oversight for Quality and Regulatory systems, as well as identifying technology solutions to meet evolving Quality and Regulatory business needs. The position aims to eliminate redundant systems and manual operations while implementing consistent and automated best practices. This role is also responsible for compliance with applicable Corporate and Divisional Policies and procedures. The Sr. IT Business Relationship Manager will consult with business process owners on tools and solutions based on their IT expertise, and collaborate closely with other disciplines like corporate IT, Engineering, and business process owners in the BU. They will influence and partner with business leaders (Manager, Director) to manage and align the process-specific IT portfolio, provide expert oversight of global medical device quality and regulatory systems and roadmaps, and ensure data integrity of FDA Reporting processes. This role involves liaising with IT, operations, and quality and regulatory business functions, and operating with broad goals and objectives, having a direct impact on capital budget, expenses, and project completion. The goal is to ensure compliance (Complaint Handling, Regulatory Reporting, eMDR, change control, etc.), improve quality, and reduce costs by optimizing and integrating quality processes, including management and reporting. The role requires facilitating conversations with stakeholders to understand, document, and solve business needs, and explaining issues and requirements from both technical and business perspectives. Collaboration with design and development teams to document business requirements, product plans, workflows, risks, and estimates in a shared services/managed services setup is essential. The Sr. IT Business Relationship Manager will analyze multifaceted business problems using data from internal and external sources to provide insights to decision-makers, conduct analysis using standard practices and tools, and resolve system defects ensuring acceptable system testing and timely deployments in collaboration with IT and external vendors. Establishing and maintaining communication channels with process owners, key team members, and internal stakeholders to support data gathering and analysis, assisting with querying data, building or modifying smart lists, and transitioning ad hoc report requirements are also key responsibilities. Maintaining system protocols by ensuring business owners update policies and procedures in accordance with QMS policies, and providing user training and process hand-off for newly released functionality and enhancements are also part of the role. The role involves understanding people, process, and technologies required for Design Controls, Post Market Surveillance, Management Controls, Process Controls, and complaint management processes, and building/maintaining expertise on the IT portfolio for clients. Proactively analyzing business processes, eliciting, analyzing, and documenting business requirements, identifying alternative solutions, assessing feasibility, and making recommendations, typically seeking to exploit and leverage new or existing IT technology components are crucial. The Sr. IT Business Relationship Manager will champion change and innovation, stimulate creativity, and be open to new ideas, while maintaining constant awareness of corporate IT standards, technology trends, evolving regulatory requirements, and their applicability to the business process and IT portfolio, influencing IT stakeholders and partners in addressing these evolutions efficiently. Managing collaboration and partnership with Corporate IT Services, including Plan/Build/Run teams, is also a key aspect of this position.

Requirements

8 to 15 Years Experience
FDA/regulatory Reporting processes
Quality
Medical device
Bachelor's degree in Engineering or related field
8+ years of Quality Systems Expertise

Responsibilities

Develop and maintain comprehensive Quality and Regulatory IT road maps for Complaints Systems.
Manage IT Capital and Expense financial projections, planning, and oversight for Quality and Regulatory systems.
Identify technology solutions to meet evolving Quality and Regulatory business needs.
Eliminate redundant systems and manual operations, while implementing consistent and automated best practices.
Ensure compliance with applicable Corporate and Divisional Policies and procedures.
Consult with business process owners on tools and solutions based on IT expertise.
Collaborate with corporate IT, Engineering, and business process owners.
Influence and partner with business leaders to manage and align the process-specific IT portfolio.
Provide expert oversight of global medical device quality and regulatory systems and roadmaps.
Ensure data integrity of FDA Reporting processes.
Liaise with IT, operations, and quality and regulatory business functions.
Ensure compliance (Complaint Handling, Regulatory Reporting, eMDR, change control, etc.), improve quality, and reduce costs by optimizing and integrating quality processes.
Facilitate conversations with stakeholders to understand, document, and solve business needs.
Understand, document, and explain issues and requirements from both technical and business points of view.
Collaborate with design and development teams to document business requirements, product plans, workflows, risks, and estimates.
Analyze multifaceted business problems and issues using data from internal and external sources.
Resolve system defects ensuring acceptable system testing and timely deployments.
Establish and maintain communication channels with process owners, key team members, and internal stakeholders.
Assist with querying data for extraction, building or modifying smart lists and transitioning ad hoc report requirements.
Maintain system protocols by ensuring business owners are updating policies and procedures in accordance with QMS policies.
Provide user training and process hand-off for newly released functionality and enhancements.
Understand people, process, and technologies required for Design Controls, Post Market Surveillance, Management Controls, Process Controls, and complaint management processes.
Build and maintain expertise on the IT portfolio for client.
Proactively analyze business processes; elicit, analyze, and document business requirements; identify alternative solutions, assess feasibility and make recommendations.
Champion change and innovation.
Manage collaboration and partnership with Corporate IT Services including Plan/Build/Run teams.