Roles and Responsibilities
Leadership & Strategy
Lead and develop the European Regulatory Affairs team, fostering a high-performance and collaborative culture.
Define and execute regulatory strategies aligned with GE HealthCare’s global objectives.
Represent Regulatory Affairs in cross-functional leadership forums and strategic initiatives.
Regulatory Compliance
Ensure compliance with EU MDR and other applicable European regulations.
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.
Operational Excellence
Drive continuous improvement in regulatory processes and systems.
Monitor regulatory changes and assess impact on GE HealthCare’s product portfolio.
Support audits, inspections, and regulatory due diligence activities.
Stakeholder Engagement
Collaborate with Quality, Legal, Commercial, and Product teams to ensure regulatory alignment.
Provide expert guidance and training on European regulatory requirements.
Represent GE HealthCare in industry associations and regulatory forums as needed.
Required Qualifications
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.
Desired Characteristics
Experience working in a global or matrixed organization.
Familiarity with digital health technologies and software as a medical device (SaMD).
Ability to influence and lead through change.
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Additional InformationRelocation Assistance Provided: No
GE Healthcare Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.
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Healthcare Strength — Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
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Retirement Support — Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
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Strong & Reliable Incentives — Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.
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What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.
