Regulatory affairs specialist Jobs in Leipheim

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our T ranscatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Your key responsibility will be developing relationships with heart failure specialists and general cardiologists , as well as in the interventional community, to increase awareness of interventional strategies for treating atrioventricular valve regurgitation. Building referral practices in the field and driving alignment, adoption and execution of clinical trial therapy development initiatives, especially focused on assigned area, will be your core duties.

Candidate location : Germany. Some level of travelling will be requested - ca. 25 - 30 % (mainly inside Germany and EU congresses, society meetings) .

Apply in English!

How you will make an impact :

• Identify restrictions to patient access within a region’s geography. Evaluate and identify creative sources and solutions that can help inform and influence the strategic business plan for patient outreach initiatives (e.g., recruitment events) for the mitral and tricuspid patient along the clinical trial continuum in collaboration with stakeholders (e.g., physicians, research coordinators). Establish an understanding of referral dynamics and how patient access may be restricted or delayed within the clinical trial pathway
• Develop new and existing relationships with HCPs (e.g., physicians and key staff) through regular outreach and education activities, referring HCP visits, product demonstration and conference participation within the clinical research
• Develop HCP- and patient-directed materials to support strategic business plan in collaboration with clinical marketing
• Provide technical expertise on devices / protocols and on-site support for patient selection, screening, imaging, Heart Team concept and clinical data across BU (TMTT mitral and tricuspid therapies)
• Define areas of opportunity along the Heart Team referral pathway to maximize their patient access to key clinical trials
• Identify, influence and meet with existing HCPs to identify clinical needs and constraints related to BU clinical trial protocol adoption
• Build timelines and key deliverables to align with overall business objective.
• Provide technical guidance on a variety of projects including identifying trial site specific bottlenecks and work with clinical affairs to refer to cross-functional partners (e.g., training, trial management, screening etc.)
• Identify and differentiate root cause of patient access restrictions between outreach and patient pathway ; Accurate tracking and documentation of all activity per clinical trial guidelines

What you'll need (Required) :

What else we look for :

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 :

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.

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