Sr Specialist, Regulatory Affairs EMEA 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:

Completes and maintains regulatory approvals and clearances of assigned products.

Key Responsibilities:

  • Create complex regulatory submissions/playbook, exercising judgment to protect proprietary information for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, develop regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in countries/area of work (e.g., country cluster, COE, Canada)
  • Identify and develop complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including proposing alternative solutions and recommendations. Execute all RA activities in Edwards systems to ensure compliant product distribution.
  • Lead portions of projects to identify trends, assess impact, analyze alternatives and recommend action plans
  • Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives and resolving conflicts between those requirements and development issues, and/or reporting to management.
  • Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies
  • Provide guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact of regulations and proposing suggestions.
  • Review and approve materials (e.g., collateral) from cross-functional teams
  • Provide training and knowledge transfer to team members
  • Other incidental duties assigned by Leadership

Education and Experience:

  • Bachelor's Degree in related field, 5 Years of previous related experience required
  • in scientific discipline (e.g., Biology, microbiology, Chemistry) Preferred
  • Other: Coursework, seminars, and/or other formal government and/or trade association training Required
  • Experience in preparing domestic and international product submissions preferred

Additional Skills:

  • Good medical writing skills
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
  • Good problem-solving, decision-making, organizational, analytical and critical thinking skills
  • Excellent written and verbal communication skills including negotiating and relationship management skills
  • Ability to read, write and speak English required; Fluency in other language (e.g., German, French, Spanish, Italian, Portuguese, Russian, Polish) preferred
  • Full knowledge and understanding of global regulations relevant to medical devices, Class I, II and/or Class III devices.
  • Full knowledge and understanding of global regulatory requirements for new products or product changes.
  • Full knowledge of new product development systems
  • Strict attention to detail
  • Good leadership skills and ability to influence change
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • 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

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