Senior Manager
Vor 5 Tagen
Job DescriptionDefine and lead the global Clinical Affairs strategy for Brainlab’s global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teamsLead and develop an international Clinical Affairs team responsible for clinical evaluation, clinical research and scientific marketing communicationEnsure clinical compliance with EU MDR, FDA and other regulatory requirementsBuild and maintain a strong clinical network of investigators, key opinion leaders and research partnersAct as Process Owner for clinical evaluation and validation, training authors and evaluators to ensure regulatory compliancePartner closely with R&D, Product Management, Marketing, Sales and Quality Management on the strategy and to translate clinical insights into product innovation and market differentiationBridge clinical research and scientific marketing by translating evidence into credible, high-impact scientific and educational contentEnsure GDPR compliance in clinical collaborationsDefine and manage clinical studies and investigations to support product innovation and regulatory approvalsRepresent the company in communications with regulatory authorities related to clinical strategy, investigations and submissionsQualificationsAdvanced scientific, medical or technical degree (PhD, MD, or equivalent preferred)Extensive experience in Clinical Affairs, Clinical Research within the medical device industryStrong background in clinical and regulatory requirements for Class I–III medical devicesDemonstrated leadership experience, including managing international or cross-functional teamsSeveral years of experience in Clinical Affairs, Clinical Research and/or R&D within the medical device industryClinical and regulatory background for Class I to Class III medical devicesIn-depth knowledge of EU MDR, FDA regulations and Good Clinical PracticeHands-on experience in clinical studies, clinical evaluations and regulatory submissions for medical devicesAbility to translate clinical research into scientific marketing contentExcellent stakeholder management, communication, and project leadership skillsSolid understanding of GDPR and clinical data protection requirementsVery good English skills, German is a plusAdditional InformationA mutually-supportive, international teamMeaningful work with a lasting impact on medical technology30 vacation days, plus December 24th and December 31stFlexible working hours as well as hybrid work model within GermanyBike leasing via cooperation partner "BikeLeasing"Parking garage and safe underground bike storageAward-winning subsidized company restaurant and in-house cafesVariety-rich fitness program in our ultra-modern 360m2 company gymRegular after work, team, and company eventsComprehensive training and continuing education opportunitiesReady to apply? We look forward to receiving your online application including your first available start date and desired salary. Contact person: Géraldine Ferrer
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