As part of the Global Regulatory Affairs Team, we offer you an exciting and responsible role in a globally operating functional area. We enable our employees to engage in interesting tasks within a modern working environment, supporting their growth and professional development. If you are enthusiastic about our meaningful product portfolio, we look forward to getting to know you.Responsibilities :
Management, registration, and implementation of applicable legal requirements regarding Regulatory Affairs for products and activities, ensuring compliance with MDD and MDR requirements for medical devices.Provide regulatory input to product lifecycle planning for medical devices, focusing on MDD / MDR compliance.Assist in developing regional regulatory strategies and updating them based on regulatory changes.Participate in risk-benefit analysis for regulatory compliance pre-market.Assist with label development and review for compliance before release.Provide regulatory input for product recalls and recall communications.Support Technical File Audits.Become the Subject Matter Expert (SME) for Biocompatibility processes.Implement regulatory requirements related to Biocompatibility.Manage technical documentation of medical devices, including clinical evaluation files for LHSA or other legal manufacturers.Assess Biocompatibility requirements for new products, projects, changes, and supplier notifications, ensuring biological safety evaluation and documentation.Coordinate with external laboratories on testing requirements, samples, quotes, protocols, and reports.Update Biocompatibility Assessments based on new testing and documentation of changes.Ensure compliance of Regulatory and Biocompatibility aspects for marketing authorization submissions and respond to regulator requests.What we look for :
University degree in Engineering, Pharmacy, or Biology.Understanding of guidelines and regulations, e.G., ISO 10993.Strong knowledge of medical device regulations, especially MDD and MDR.Knowledge of ISO 13485, FDA practices, GMP, or similar standards.1-3 years of experience in a regulated industry in a similar role.Proficiency in Spanish and English, both written and spoken.The original job posting can be found at :
Kit Empleo
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