XE
Xcel EnergyRegulatory Policy Specialist
Regulatory Policy Specialist developing regulatory case filings and strategies at Xcel Energy. Collaborating with senior management to ensure compliance and effective communication with stakeholders.
About the role
- Manage product label and UDI data changes in compliance with relevant QMS processes.
- Collaborate with stakeholders to gather, transform, and verify accurate label content.
- Maintain and update labeling procedures to ensure regulatory compliance and operational efficiency.
- Partner closely with internal “label customers” to support departmental and business needs.
- Lead or contribute to continuous improvement initiatives in Label Development and standardization.
- Investigate and resolve non-conformance issues with internal teams and suppliers, implementing effective corrective actions.
- Support the design, testing, and implementation of labeling software tools and systems.
- Train and support end users on labeling processes and tools to promote best practices.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Quality Management, Engineering, or a related field.
- Minimum 2 years of experience in label data management, regulatory, or quality functions within a highly regulated industry (e.g. medical device, pharmaceutical, or food).
- Hands-on experience with labeling or quality software such as Prisym, Robar, Bartender, or similar.
- Proficiency in Microsoft Suite (Excel, Power BI, etc.).
- Excellent English communication skills, enabling effective collaboration with global and local stakeholders.
- Preferred: German language skills.
- Strong project management abilities and experience leading cross-functional collaboration.
- Familiarity with EU MDR, ISO 13485, FDA 21 CFR Part 820, and other global quality standards.
Benefits
- Flexible working hours
- Opportunity to work partially from the home office
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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