Director, MedTech Safety

Warsaw, PolandAunque la experiencia profesional y las cualificaciones son clave para este puesto, asegúrese de comprobar si posee las habilidades interpersonales preferibles antes de solicitar, si

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Lisbon, PortugalBarcelona, SpainBerchem, BelgiumFull timeR1567079Essential FunctionsMedical Device Safety LeadershipProvide 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 LeadershipLead, 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 LeadershipServe 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 ManagementProvide 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 LeadershipIdentify 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 global 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.
QualificationsRequiredBachelor'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 programs or studies.
Experience with client-facing delivery and senior stakeholder management.
Demonstrate