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
- Provide regulatory strategy and direction for pre-market product launches and registrations
- Lead and develop the European Regulatory Affairs team and define regulatory strategies aligned with global objectives
- Act as PRRC under MDR, ensuring product conformity and regulatory documentation integrity
- Oversee regulatory submissions, CE marking processes, and interactions with Notified Bodies and Competent Authorities
- Monitor regulatory changes and assess impact on product portfolio
- Support audits, inspections, and regulatory due diligence activities
- Collaborate with Quality, Legal, Commercial, and Product teams and represent Regulatory Affairs in cross-functional leadership forums
- Provide expert guidance and training on European regulatory requirements
- Drive continuous improvement in regulatory processes and systems
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field
- Minimum 10 years of experience in Regulatory Affairs, with significant exposure to European medical device regulations
- Proven leadership experience, including team management and strategic planning
- Fluent in German and English (written and spoken)
- Must be based in the European Union and meet the qualifications to act as PRRC under MDR
- Strong knowledge of EU MDR, IVDR, and relevant guidance documents
- Excellent communication, negotiation, and stakeholder management skills
- Experience working in a global or matrixed organization (desired)
- Familiarity with digital health technologies and software as a medical device (SaMD) (desired)
- Ability to influence and lead through change (desired)
Job title
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