Regulatory Affairs Specialist (Temporary position)

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.

How you'll make an impact

• To ensure patients have access to innovative, high quality, safe and effective solutions to hemodynamic monitoring by obtaining Health Agency Medical Device approvals in compliance with local regulation Standards by being responsible of Regulatory Affairs activities within the respective country(ies).
• Create regulatory submissions, 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, Center of Excellence)
• Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies.
• 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.
• Identify trends, assess impact, analyze alternatives, and recommend action plans.
• 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.
• Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact to appropriate regulation
• Review and approve promotional materials (e.g., collateral) from cross-functional teams
• Manage local Establishment Regulatory Authorization, when applicable
• Partner with CoE team in the Review of local generated promotional materials to comply with local regulatory requirements when needed
• Interaction with QA for FCA & vigilance reports , Facilitate Q&As with local CAs for FCA , adverse events & vigilance reports
• Assist with special projects on as -needed basis

• Bachelor's Degree in related field, 3 years experience 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
• Preferred Experience in preparing domestic and international product submissions
• Advanced Portuguese and Spanish
• Intermediate English
• Knowledge of Brazilian regulation

• 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
• 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
• Strict attention to detail
• 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 representing the organization on specific projects
• Ability to build productive internal/external working relationships
• 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