The role involves developing and implementing clinical evidence strategies to support global regulatory submissions and product development. You will oversee the creation of clinical regulatory documentation and collaborate with cross-functional teams to ensure device safety and performance.
The Senior JD Edwards Analyst will act as a techno-functional lead responsible for configuring, maintaining, and optimizing JDE EnterpriseOne modules. They will bridge the gap between business needs and IT solutions by translating requirements into specifications and supporting major IT initiatives.
The role involves leading global regulatory strategies, preparing and submitting regulatory dossiers, and mentoring the team on compliance and regional regulations. You will also act as a project stakeholder to drive value, negotiate with authorities, and oversee post-market changes and acquisition integration.
Lead complex cross-functional RAQA projects from initiation to completion while managing project plans, budgets, and stakeholder communication. Ensure compliance with global regulatory standards and quality systems while driving continuous improvement in project management processes.
The role involves developing and leading global regulatory strategies while mentoring the team on local and international regulations. You will also manage regulatory submissions, oversee post-market changes, and ensure compliance across clinical and manufacturing processes.
The Program Manager will oversee program documentation, budget monitoring, and risk assessments while coordinating with cross-functional teams to deliver business value. They are responsible for leading resource planning, mentoring team members, and driving collaboration to resolve project conflicts and scope changes.
Define and execute a 12-24 month data modernization roadmap and architecture to support business priorities. Lead a team of analysts and engineers to deliver dashboards and analytical models across manufacturing, supply chain, sales, and finance.
The role involves administering sales compensation plans, territory design, and quota planning while maintaining accurate commercial organizational data. Additionally, the analyst will develop Power BI dashboards and partner cross-functionally to improve sales operations processes.
The role involves authoring and managing regulatory submissions, such as 510(k)s and technical documentation, to secure product approvals. The specialist will interface with the FDA and other health authorities while reviewing engineering changes and maintaining regulatory information systems.
