Manager, Regulatory Affairs

  • Full time
  • Prague
  • Posted 1 week ago

Edwards Lifesciences

This Manager, Regulatory Affairs will develop and lead the implementation of a robust control infrastructure and governance within Regulatory Affairs inclusive of processes, procedures, operational standards and systemically driven controls that support compliance with regulatory requirements.

Further will develop and plan multiple regulatory affairs projects and activities ( RA Operations) including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables.

Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives on regulatory changes and opportunities
Identify and evaluate regulatory affairs process improvements and/or course correction/course alignment opportunities focusing on operational excellence.

Review of the position:

  • Be recognized as an expert in own area with specialized depth within the organization 
  • Become an expert in understanding of related aspects of Regulatory Affairs processes and/or systems
  • Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends
  • Interpret internal or external business issues and recommends solutions/best practices
  • Education and Experience:

  • Other: scientific discipline (, Biology, Microbiology, Chemistry) is preferred
  • Proven successful project management skills
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Ability to read, write and speak English required; Fluency in other language (, German, French, Spanish, Italian, Portuguese, Russian, Polish) is preferred
  • Additional Skills:

  • Ability to work in a matrix environment
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
  • Ability to manage competing priorities in a fast paced environment
  • Represents leadership on projects within a specific area interfacing with project managers and Regulatory Affairs team
  • Consult in project setting within specific Regulatory Affairs area
  • What is it like to work at Edwards Lifesciences in the Czech Republic?  

    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 Czech Republic also offers the following benefits:

  • Competitive Compensation and Benefits package
  • Flexible working hours, remote working
  • Pension Plan Risk Life Insurance
  • Virtual Medical Clinic (online access to healthcare)
  • Meal Benefits
  • Service Awards
  • Enhanced Sick Leave Benefits
  • Flexible Benefit Plan (Cafeteria)
  • Employee Stock Purchase Program
  • Employee Assistance Program
  • Comprehensive Wellness Program including onsite gym, Yoga, Pilates or SM System classes, massages, fresh fruit in the office, healthy lifestyle workshops, 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. 

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