Team Lead - Clinical Affairs

Stellenbeschreibung:

Define and lead the global Clinical Affairs strategy for Brainlabs global surgery portfolio ensuring alignment with product regulatory and commercial objectives / teams
Lead and develop an international Clinical Affairs team responsible for clinical evaluation, clinical research and scientific marketing communication
Ensure clinical compliance with EU MDR, FDA and other regulatory requirements
Build and maintain a strong clinical network of investigators, key opinion leaders and research partners
Act as Process Owner for clinical evaluation and validation training authors and evaluators to ensure regulatory compliance
Partner closely with R&D, Product Management, Marketing, Sales and Quality Management on the strategy and to translate clinical insights into product innovation and market differentiation
Bridge clinical research and scientific marketing by translating evidence into credible high-impact scientific and educational content
Ensure GDPR compliance in clinical collaborations
Define and manage clinical studies and investigations to support product innovation and regulatory approvals
Represent the company in communications with regulatory authorities related to clinical strategy, investigations and submissions

Advanced scientific, medical or technical degree (PhD, MD or equivalent preferred)
Extensive experience in Clinical Affairs and Clinical Research within the medical device industry
Strong background in clinical and regulatory requirements for Class IIII medical devices
Demonstrated leadership experience including managing international or cross‑functional teams
Several years of experience in Clinical Affairs, Clinical Research and/or R&D within the medical device industry
Clinical and regulatory background for Class I to Class III medical devices
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 stakeholder management, communication and project leadership skills
Solid understanding of GDPR and clinical data protection requirements
Very good English skills; German is a plus