Sr Mgr, Regulatory Affairs Critical Care

1 month ago

Prague, Hlavní město Praha, Czech Republic Edwards Lifesciences Full time

For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who should be monitored will be monitored with smart technology.

If you're eager to contribute your expertise and commitment to Critical Care's mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.

Appendix:

On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards' announcement about the acquisition can be found here:

Responsibilities:

  • Lead the Product life cycle management of new products, product changes and renewals submissions for product applications or country notifications in EMEACLA.
  • 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.
  • Develop and plan multiple regulatory affairs projects and activities (e.g., RA Product Lifecycle and Operations, clinical submission writing) including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables.
  • ​Lead Knowledge Management initiatives through development of RA submission requirements matrix and other crucial information.
  • 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 and approve materials (e.g., collateral) from cross-functional teams.
  • Other incidental duties.

Education/Experience

  • 8- 10 years of relevant work experience in Regulatory Affairs within Pharma and/or Medical Devices.
  • Extensive experience in regional regulatory environment.
  • Proven track record of developing and executing regional regulatory strategy.
  • In-depth understanding of the product life cycle and development process from a regulatory perspective.
  • Experience in preparing domestic and international product submissions.
  • Coursework, seminars, and/or other formal government and/or trade association training.
  • Good medical writing skills.
  • 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).
  • Bachelor's Degree in relevant field such as scientific discipline (e.g., Biology, Microbiology, Chemistry).

Additional Skills:

  • Ability to work in a matrix environment.
  • Proven expertise in both Microsoft Office Suite, including advanced Excel and Regulatory Affairs systems.
  • Expert understanding of related aspects of Regulatory Affairs processes and/or systems.
  • Strict attention to detail.
  • Ability to manage competing priorities in a fast-paced environment.

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