Regulatory Affairs Specialist I (LATAM) Tiempo Completo NUEVO

Expectations and Accountabilities:
– Prepare and submit regulatory dossiers for product approvals, renewals and amendments

• Ensure regulatory compliance and provide local regulatory assessment and pathway(s)
• Determine regulatory filing strategies and submission types
• Reads, reviews, interprets and keeps current with regulations and publications regarding medical devices and PPE products with primary focus on medical devices communicate updates to internal stakeholders
• Manages necessary corrective action in all areas of responsibility which leads to improved product quality, process efficiency, minimum corporate exposure, and maximum profitability
• Ensures that all necessary quality assurance, regulatory and validation procedures and policies are in place and up to date
• Manages company regulation and documentation programs including development and distribution of standard operating procedures (SOPs), policies, and technical reports
• Maintain regulatory files and databases to ensure completeness, accuracy, and readiness for audits or inspections
• Directs and reviews company self-audit and corrective action programs to ensure compliance with Good Manufacturing Practices (GMPs) and Medical Device amendments
• Maintains appropriate relationships with regulatory governmental agencies by serving as a liaison
• Active participation and support for all continuous improvement and SOP efforts which leads to increased productivity, profitability, and customer satisfaction in areas of responsibility
• Provides technical assistance and consultation to marketing, sales, and customers regarding Technical Data Sheet, tenders letters, and required certificates
• Reviews and approves promotional materials for use in markets of responsibility
  Provides assistance to contracts, maintain local Quality Agreements updated, manage Purchase Orders and Payments to local QARA service providers.
  Education and Experience:
  – Bachelor’s degree in biological sciences, microbiology chemistry or engineering required; Graduate studies in Regulatory Affairs preferred
• RAC certified professional and project management skills desirable
• 3+ years’ experience in Regulatory Affairs in a medical device company
• Experience in dealing with FDA, Notified Bodies and other regulatory agencies
• Working knowledge of ISO and applicable International regulations, compliance and audit practices
• Intermediate level proficiency in Microsoft Office programs (Excel, PowerPoint, Word)
• Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision
• 5% domestic travel.
• Strong attention to detail and organizational skills.
• Ability to manage multiple tasks and meet deadlines in a dynamic environment.
• Moderate proficiency in English (reading, writing, and speaking)

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