Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

Edwards Lifesciences

Prague, Czech Republic

This Senior Regulatory Affairs Manager 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 (e.g. 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:

  • Bachelor's Degree with 5 years of relevant work experience is required
  • Other: scientific discipline (e.g., 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 (e.g., 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

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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