Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you’ll make an impact:

• Provide medical oversight and input aligned with patient-focused mission, ensuring a strong emphasis on patient safety across product use. Align efforts with business objectives, Good Clinical Practice, and regulatory requirements for all ongoing clinical trials.
• Review safety reports: analyze serious adverse events (SAEs) and assess potential device/system related and implant procedure-related events to ensure timely and appropriate reporting and action.
• Evaluate patient eligibility: Assess and confirm patient suitability for trial participation, including training sites on effective screening considerations and implementation of inclusion/exclusion criteria.
• Provide medical guidance: Serve as physician/medical liaison to the clinical trial team, acting as a point of contact for protocol and medical questions from the internal stakeholders and/or clinical trial sites. Collaborate with CRO clinical research associates to provide expert insight on trial-related medical issues.
• Deliver medical training and support: Offer continuous support to ensure compliance with trial protocols and safety guidelines.
• Participate in investigator meetings: Attend, contribute to, and present at investigator meetings, providing medical insights and addressing trial-related concerns.
• Ensure adherence to Good Clinical Practices, product safety standards, and standard operating procedures, as well as all other applicable quality standards in the conduct of clinical research.
• Perform other incidental duties as assigned by management.

What you'll need (Required):

• Medical degree required, preferably with a background in internal medicine, cardiology, or a related field.
• Alternatively, a nursing or other clinical background with a relevant degree and/or hands-on experience in medical device safety will also be considered.
• Prior experience providing medical or safety oversight in clinical trials, ideally within the medical device industry.
• Familiarity with regulatory frameworks, and a solid understanding of risk management and safety reporting requirements.
• Strong knowledge of clinical trial documentation, including trial management requirements, relevant regulations, and operational aspects of clinical trials.
• Experience with clinical research in Cardiology or other high-risk therapeutic areas.
• Willingness and ability to travel.
   

What else we look for (Preferred):

• Strong communication skills with an ability to collaborate effectively across multidisciplinary and international teams.
• High level of motivation with ability to stay composed under pressure and desire to support others.
• Organizational skills with ability to prioritize, manage complexity, and meet deadlines within a dynamic cross-functional setting.
• Excellent collaboration and community-building skills with ability to build trust and foster productive partnerships with both internal and external stakeholders.
• Demonstrated ability to manage competing priorities while maintaining a high level of accountability.
• Critical thinking and problem-solving skills with solution-oriented mindset.
• Proficiency in Microsoft Office applications and digital tools commonly used in clinical and regulatory environments.

What is  it  like  to work at  Edwards  Lifesciences  in  Germany?

As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).  

Edwards  Lifesciences  in  Germany  also  offers  the  following  benefits:

• Competitive  Compensation  and  Benefits  package
• Flexible  working  hours,  remote  working
• Pension  plan Risk  
• Insurance Meal  Benefits  
• Service  Awards Enhanced  
• Leave  Benefits
• Transportation  Benefits
• Employee  Stock  Purchase  Programme
• Employee  Assistance  Programme
• Comprehensive Wellness  Programme  including  onsite  gym,  yoga classes  and  massage,  preventive health  checks,  healthy  lifestyle  webinars,  educational events,  charity  activities  and  much  more.

Benefits  are  regulated  by  an  internal policy  which  contains  the full  details regarding  the entitlement and  conditions  for  the  benefits.  Benefits  policy and  components  may  vary  by  location.