Edwards Lifesciences is growing and our Senior Director Regulatory Affairs, Europe, Endotronix position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth.

For more details on the acquisition, please visit: https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port

How you will make an impact:

Manage all Regulatory Affairs activities within the respective countries.

Key Responsibilities:

• Develop and plan multiple and extremely complex regulatory affairs projects and activities within program(s) including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables
• Identify and evaluate complex and/or advanced regulatory affairs process improvements and/or course correction/alignment opportunities to accelerate route to market access in collaboration with key stakeholders.
• Responsible for full execution of strategy and contingency plans for projects. Determine strategy, impact and synergies across the RA organization.
• Serve in an advisory role to management to provide direction and guidance to project teams to execute extremely complex projects within program(s), initiatives and/or programs. Interact with regulatory authorities for significant projects and may provide on-site audit oversight.
• Frequently anticipate and advise on future regulatory trends and direction, and industry best practices, and lead the implementation of preemptive approaches for company regulatory compliance.
• Influence regulations and guidance through relationships with regulatory agencies and external organizations (e.g., AdvaMed, standards committee).
• Review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy
• Other incidental duties
  
  

What you'll need (Required):

• Education and Experience:
• Bachelor's Degree in in related field
• 14 years years experience of previous related experience Required or
• Master's Degree or equivalent in in related field , 12 years years experience of previous related experience Required and
• Experience working in a large manufacturing company Preferred
  
  

What else we look for (Preferred):

Additional Skills:

• Proven successful project management skills
• Proven expertise in Microsoft Office Suite, including advanced Excel and regulatory affairs systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Recognized as an expert within field and within the organization, both within and beyond own function
• Expert understanding of related aspects of regulatory affairs processes and/or systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on programs or org-specific strategic initiatives within multiple areas, interfacing with project managers, regulatory affairs team and leadership team
• Consult in program setting within multiple regulatory affairs areas, deeper or more dedicated advisory role, interfacing with more senior management
• Provides regulatory affairs leadership to outsourcing partners on a directive level, participates on medium scale RFP
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
  
  

What is it like to work at Edwards Lifesciences in the United Kingdom?

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 the United Kingdom also offers the following benefits:

• Competitive Compensation and Benefits package
• Flexible working hours, remote working
• Pension Scheme (double matching)
• Risk Life Insurance and Group Income Protection
• Private Medical Plan
• Service Awards
• Enhanced Sick Leave Benefits (Income Protection)
• Employee Stock Purchase Program
• Employee Assistance Program
• Comprehensive Wellness Program including health and wellness subsidy, onsite gym, massages, fresh fruit in the office, financial webinars, discount cards 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.