Shape Quality, Safety, and Innovation in a Regulated Environment For an innovative company in the
Medical Devices, Pharmaceutical, or Life Sciences
sector, we are looking for a committed and experienced professional to join as a
Senior Risk Management (m/f/d) . In this role, you will play a key part in assessing, controlling, and communicating product and process risks, contributing significantly to the successful development, validation, and regulatory approval of new products and processes. Your Responsibilities Plan, organize, execute, and document scientific experiments, GMP testing activities, and technical equipment-related operations. Develop, optimize, and implement methods, processes, and technologies throughout the product lifecycle. Prepare, maintain, and review scientific and regulatory documentation, including reports, protocols, SOPs, and regulatory submissions. Apply and further develop risk management processes in accordance with relevant standards and regulations, such as FMEA and ISO 14971. Create and maintain risk management documentation and technical documentation packages (e.g., DHF, DMR). Conduct risk analyses and derive well-founded mitigation strategies and recommendations. Support design verification, process control, and validation activities. Analyze, interpret, and present experimental results, and plan follow-up investigations where necessary. Communicate project, product, and process risks effectively within cross-functional teams. Collaborate with external partners, suppliers, auditors, and regulatory authorities. Ensure compliance with quality, safety, environmental, and regulatory requirements, including cGMP standards. Identify opportunities for optimization and actively contribute to continuous improvement initiatives. Support, advise, and train team members to foster knowledge sharing and professional development. Your Profile Completed university degree (Master's, Diploma, or equivalent) in Engineering, Life Sciences, or a related field such as Medical Engineering, Mechanical Engineering, Process Engineering, Biotechnology, or similar. Several years of professional experience in risk management, preferably within the Medical Device, Pharmaceutical, or Life Sciences industry. Strong expertise in risk management methodologies and tools, including FMEA and ISO 14971 requirements. Experience working with regulatory requirements and quality standards, particularly GMP/cGMP. Excellent analytical and problem-solving skills, with a structured and self-driven approach to work. Fluency in English, both written and spoken. Strong communication skills and enthusiasm for interdisciplinary collaboration. What We Offer A highly responsible role with strong visibility and direct impact on product quality and patient safety. The opportunity to work in an international and interdisciplinary environment. Challenging projects across the entire product development lifecycle. The chance to actively shape processes and drive continuous improvement initiatives. A modern working environment with attractive career development opportunities in a future-oriented industry. Join a team that combines innovation with the highest standards of quality and regulatory excellence.
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Senior Risk Management Specialist (w/m/d) | Medical Devices & Life Sciences Arbeitgeber: Brunel
Als Servicetechniker Elektrotechnik / Tanktechnik im Großraum Köln profitieren Sie von einer unbefristeten Festanstellung in einem expandierenden Unternehmen, das Wert auf individuelle Weiterbildung und persönliche Entwicklung legt. Unsere Unternehmenskultur fördert Teamarbeit und Kundenorientierung, während ein Haustarifvertrag faire Gehälter und umfassende Sozialleistungen garantiert. Arbeiten Sie in einem dynamischen Umfeld, das Ihnen die Möglichkeit bietet, Ihre Fähigkeiten in der Wartung und Instandhaltung technischer Anlagen weiter auszubauen.
