Spec, Regulatory Affairs

Edwards Lifesciences - São Paulo, SP

Key Responsibilities:

  • Create regulatory submissions/playbook, exercising judgment to protect proprietary information) for finalization and submission; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in assigned countries/area of work (e.g., country clusters, COE, Canada) Or Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activities in Edwards systems to ensure compliant product distribution.
  • Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, 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
  • Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact to appropriate regulations
  • Identify trends, assess impact, analyze alternatives and recommend action plans
  • Review and approve materials (e.g., collateral) from cross-functional teams
  • Other incidental duties as assigned by Management

Education and Experience:
  • Bachelor's degree in related field required; scientific discipline (e.g., Biology, Microbiology, Chemistry) preferred
  • Coursework, seminars, and/or other formal government and/or trade association training required
  • 3 years of previous related experience required; Experience in preparing domestic and international product submissions preferred
  • 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
  • Good written and verbal communication skills and interpersonal relationship skills
  • Ability to read, write and speak English required; Fluency in other language (e.g., German, French, Spanish, Italian, Portuguese, Russian, Polish) preferred

Additional Skills:
  • Solid knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices)
  • Solid knowledge and understanding of global regulatory requirements for new products or product changes.
  • Solid knowledge of new product development systems
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