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Regulatory Compliance Specialist

2 meses atrás

São Paulo, São Paulo, Brasil Edwards Lifesciences Tempo inteiro

Make a significant impact on global health outcomes. Our Regulatory Affairs teams play a crucial role in navigating intricate international regulatory landscapes, ensuring that our innovative medical technologies are compliant and accessible. By collaborating with external regulatory bodies and diverse internal teams, your expertise and meticulous attention to detail will facilitate the delivery of our products to healthcare professionals, ultimately enhancing patient care.

Key Responsibilities:

  • Ensure the availability of innovative, high-quality, and safe hemodynamic monitoring solutions by securing Health Agency Medical Device approvals in accordance with local regulatory standards, taking charge of Regulatory Affairs functions within designated regions.
  • Develop and manage regulatory submissions, tracking timelines and documenting progress, while contributing to the formulation of regulatory strategies and aligning activities with operational plans.
  • Prepare comprehensive documentation for submissions, ensuring all necessary forms are completed for relevant regulatory authorities.
  • Identify and implement process improvement initiatives within Regulatory Affairs, including system enhancements and training programs, while executing all regulatory activities in compliance with internal systems.
  • Analyze trends, evaluate impacts, and propose actionable plans based on regulatory insights.
  • Represent the regulatory function in product development and manufacturing teams, providing guidance on regulatory requirements and addressing any conflicts that may arise.
  • Offer strategic advice and feedback to stakeholders regarding regulatory processes, including registration requirements and contingency strategies.
  • Review and approve marketing materials produced by cross-functional teams to ensure compliance with regulatory standards.
  • Manage local Establishment Regulatory Authorization as required.
  • Collaborate with the Center of Excellence team to review locally generated promotional materials for regulatory compliance.
  • Engage with Quality Assurance on vigilance reports and facilitate communication with local authorities regarding adverse events.
  • Assist with special projects as needed.

Qualifications:

  • Bachelor's Degree in a relevant field with a minimum of 3 years of related experience.
  • Preferred background in scientific disciplines such as Biology, Microbiology, or Chemistry.
  • Experience in preparing both domestic and international product submissions is advantageous.
  • Proficiency in Portuguese and Spanish, with intermediate English skills.
  • Familiarity with Brazilian regulatory frameworks.

Additional Skills:

  • Strong medical writing capabilities.
  • Proficient in Microsoft Office Suite, including Word, PowerPoint, and Excel.
  • Excellent problem-solving, decision-making, organizational, analytical, and critical thinking skills.
  • Effective written and verbal communication skills, with strong interpersonal abilities.
  • Solid understanding of global regulations pertaining to medical devices, including knowledge of new product development systems.
  • Attention to detail and the ability to manage multiple priorities in a dynamic environment.
  • Ability to foster productive relationships across various organizational levels.
  • Commitment to adhering to company policies and environmental health and safety standards.