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n. Lisbon, Portugal Barcelona, Spain Berchem, Belgium Full time R1567079 Essential Functions Medical Device Safety Leadership
* Provide senior leadership and oversight for safety activities supporting Medical Device clinical studies, with a particular focus on studies conducted in Europe.
* Ensure appropriate execution of expedited and periodic safety reporting to EU Ethics Committees and Competent Authorities.
* Oversee preparation and delivery of annual and periodic safety/progress reports.
* Serve as a senior Safety subject matter expert for clients, internal stakeholders, operational teams, and integrated partners.
* Provide guidance on European Medical Device safety requirements and ensure operational processes meet applicable regulatory, contractual, quality, and reporting requirements.
* Partner with US Safety team and cross-functional leaders to resolve complex operational, regulatory, and client issues. Team Leadership
* Lead, develop, and manage a team of Safety Specialists and Safety Managers.
* Support the continued build-out of the Safety organization as additional positions are approved and client work expands.
* Provide day-to-day leadership, coaching, workload oversight, performance management, and professional development.
* Ensure appropriate staffing, resource allocation, utilization, training, and operational readiness across the team.
* Establish clear accountability for quality, timelines, compliance, and client delivery.
* Foster a collaborative, solutions-oriented culture focused on accountability, ownership, and continuous improvement. Client and Program Leadership




* Serve as a senior point of contact for assigned clients and programs, establishing strong and trusted client relationships.
* Oversee scope, objectives, timelines, quality, and delivery for assigned Safety programs.
* Ensure appropriate communication and escalation channels are maintained with clients and internal stakeholders.
* Lead resolution of significant quality concerns, operational issues, and customer escalations.
* Partner with customers to establish working practices, KPIs, SLAs, quality expectations, and processes for ongoing oversight.
* Provide strategic consultation regarding Safety delivery and recommend solutions based on evolving client and program requirements.
* Represent Safety in governance meetings, steering committees, operational reviews, and other high-visibility client forums. Operational and Financial Management
* Provide oversight of the financial and operational performance of assigned Safety work.
* Manage and monitor revenue, billing, utilization, budgets, resourcing, and financial performance.
* Ensure resources and staffing plans remain aligned with current and anticipated client demand.
* Monitor program-level quality, productivity, utilization, and financial metrics and implement corrective actions when needed.
* Support adherence to change-control processes and ensure changes in scope are appropriately assessed, documented, and reflected financially.




* Partner with operational and commercial stakeholders as the team's responsibilities and book of business evolve. Business and Strategic Leadership
* Identify opportunities for repeat business and additional client services based on customer needs.
* Participate in RFPs, proposals, solution development, budgeting, and customer presentations.
* Provide Safety subject-matter expertise in the development of operational solutions for new opportunities.
* Assess the operational feasibility, staffing requirements, regulatory considerations, and financial impact of proposed solutions.
* Support development and negotiation of scopes of work, budgets, work orders, service-level agreements, and other applicable contractual documentation.
* Lead or contribute to integral initiatives designed to improve Safety delivery, processes, systems, oversight, and service offerings.
* Collaborate across functions to develop practical solutions and ensure consistent delivery across programs and geographies. Qualifications Required
* Bachelor's degree, preferably in a health science, life science, nursing, pharmacy, or related discipline, or an equivalent combination of education, training, and relevant experience.
* At least 10 years of progressive Safety, clinical safety, or related experience within a CRO or Medical Device environment.
* Demonstrated experience supporting Medical Device clinical studies.
* Working knowledge and practical experience with European Medical Device safety requirements and EU safety reporting, including interactions or submissions involving Ethics Committees and Competent Authorities.
* At least 3-5 years of leadership, people-management, or line-management experience.
* Experience leading Safety professionals and managing priorities across multiple

📌 Director, MedTech Safety (Barcelona)
🏢 Confidential
📍 Barcelona