Lead and manage the Clinical Affairs team, covering clinical evaluation/validation, clinical research and scientific marketing
Oversee clinical studies, investigations and evaluations, ensuring compliance with EU MDR, FDA and other regulatory requirements
Work cross-functionally with R&D, Marketing, Sales, Product Management and Quality Management
Manage collaborations with CROs and external clinical suppliers
Act as Process Owner for clinical evaluation and validation, training authors and evaluators to ensure regulatory compliance
Serve as Clinical Evaluator for Class I to Class III medical devices
Bridge the gap between clinical research and scientific marketing to generate impactful content
Ensure GDPR compliance in clinical collaborations
Initiate and manage clinical studies and investigations to support product innovation and regulatory approvals
Build and maintain a strong clinical network in Neurosurgery
Represent the company in communications with regulatory bodies for clinical trial approvals and regulatory submissions

Technical university degree
Strong leadership experience with cross-functional collaboration
Several years of experience in Clinical Affairs, Clinical Research and/or R&D within the medical device industry
In-depth knowledge of EU MDR, FDA regulations and Good Clinical Practice
Hands-on experience in clinical studies, clinical evaluations and regulatory submissions for medical devices
Ability to translate clinical research into scientific marketing content
Excellent project management, stakeholder management and communication skills
Strong understanding of GDPR and clinical data protection regulations
Very good English skills, German is a plus

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.

Contact person: Géraldine Ferrer

Senior Manager - Clinical Affairs

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