Regulatory Affairs Specialist I (LATAM)

Expectations and Accountabilities: Prepare and submit regulatory dossiers for product approvals, renewals and amendmentsEnsure regulatory compliance and provide local regulatory assessment and pathway(s)Determine regulatory filing strategies and submission typesReads, 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 stakeholdersManages necessary corrective action in all areas of responsibility which leads to improved product quality, process efficiency, minimum corporate exposure, and maximum profitabilityEnsures that all necessary quality assurance, regulatory and validation procedures and policies are in place and up to dateManages company regulation and documentation programs including development and distribution of standard operating procedures (SOPs), policies, and technical reportsMaintain regulatory files and databases to ensure completeness, accuracy, and readiness for audits or inspectionsDirects and reviews company self-audit and corrective action programs to ensure compliance with Good Manufacturing Practices (GMPs) and Medical Device amendmentsMaintains appropriate relationships with regulatory governmental agencies by serving as a liaisonActive participation and support for all continuous improvement and SOP efforts which leads to increased productivity, profitability, and customer satisfaction in areas of responsibilityProvides technical assistance and consultation to marketing, sales, and customers regarding Technical Data Sheet, tenders letters, and required certificatesReviews and approves promotional materials for use in markets of responsibilityProvides 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 preferredRAC certified professional and project management skills desirable3+ years’ experience in Regulatory Affairs in a medical device companyExperience in dealing with FDA, Notified Bodies and other regulatory agenciesWorking knowledge of ISO and applicable International regulations, compliance and audit practicesIntermediate level proficiency in Microsoft Office programs (Excel, PowerPoint, Word)Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision5% 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)

Creado: Jue, 01 de Ene de 1970