Overview As Regulatory Affairs Specialist for Southern Europe, you will own regulatory activities across Greece, Spain, Portugal, Italy and Malta to enable timely product registrations and ongoing compliance. You will partner with Competent Authorities and cross-functional teams to support launches and lifecycle activities in a mission-driven company focused on women’s health. You will monitor evolving regulations, provide compliant documentation, and drive regulatory strategy with a pragmatic approach. Your work directly impacts product availability and patient outcomes across Southern Europe, contributing to regulatory excellence in EMEA. This is a growth-focused role with regional visibility and a Compensaciones / Incentivos * pension and insurances * salary 40,000–50,000 gross per year * comprehensive benefits package * career development opportunities Responsabilidades * Manage regulatory notifications and registrations for medical devices across Southern Europe * Serve as main contact with Competent Authorities for assigned countries * Review literature to support registrations and ongoing compliance * Approve documentation, labeling, and promotional materials for regulatory alignment * Maintain regulatory records, in-country requirements, and product documentation * Monitor regulations and communicate updates to the RA team * Support regulatory activities for new product launches and cross-functional core teams * Respond to regulatory inquiries from distributors, customers, and internal stakeholders * Provide regulatory support for tenders with timely responses * Represent RA in meetings and follow up on actions * Provide regional RA support and maintain shared platforms; report progress to RA EMEA Requisitos principales * 5+ years in regulatory within life sciences, ideally medtech and product registration * Fluent English and Spanish; Italian and Portuguese are a plus * Strong analytical skills and attention to detail * Problem-solving with pragmatic, compl

📌 Regulatory Affairs Specialist (Marbella)
🏢 Hologic
📍 Marbella