Head of CA/RA (gn)

The Freiburg-based med-tech start-up CorTec creates new ways of harnessing technology to communicate with the brain or other part of the nervous system to treat disease.  Of late, there is an increasing interest in neural implants suitable for closed-loop interaction with the human cerebral cortex.  One of CorTec’s primary technologies is designed for complex, adaptive (closed-loop) neuromodulation for measurement of neuronal activity and stimulation of neuronal tissue, for both research and therapy development in a variety of disabling conditions (e.g. stroke rehabilitation, motor impairment, chronic pain, etc.)

Our employees embrace neurotechnology in their lives and bring their knowledge to processes and designs to find unique solutions tailored to our customers' needs. Great ideas drive us forward - become part of our team and shape the future of neuromodulation with us!

As Head of RA/CA/QM you will be responsible for leading, monitoring, and implementing regulatory, clinical and reimbursement
strategies and processes in the realm of medical technology and clinical processes. You will play a central role in ensuring our products' compliance with national and international regulations, standards, and guidelines. You will lead and manage the Regulatory&Clinical Affairs/Quality Management department. You are member of our Senior Leadership Team.

In this key leadership role you will be responsible for driving the clinical strategy, overseeing clinical trials and ensuring regulatory compliance to support the successful development and commercialization for our cutting-edge medical technologies. Ideally you have extensive experience in clinical affairs (clinical study design, clinical evidence, and clinical operations) within the medical technology sector.  Strategic thinking and strong leadership skills are your core competencies as well as your commitment to advancing patient care through innovative solutions. You will lead a high-performing Clinical & Regulatory Affairs/Quality Management department and are a integral member of our Senior Leadership Team.
 

Your tasks:

• Define and implement a comprehensive clinical, regulatory, and reimbursement go-to-market strategy to ensure our success.  Responsible for maintaining department budgets and key project timelines; monitoring progress and reporting to internal and external stakeholders
• Define and monitor the execution of necessary clinical studies and projects (internationally and across sites).
• Monitor and evaluate applicable laws, regulations, and guidelines (e.g. US FDA. ISO / EN, EU / EU MDR, others as defined) pertaining to our technologies.
• Responsible for the statistical analysis and evaluation of clinical data.
• Continuous collaboration in project teams for new and further product developments from product definition to market launch.
• Support clinical/regulatory affairs team with product registrations.
• Prepare customized clinical data packages for Advisory Board, Investigators based on scientifically credible claims.
• Lead and develop department staff.

• Bachelor‘s or higher degree in fields such as Medical Technology, Biomedical Engineering, Engineering, or a related field. MD preferred.
• Minimum of 5 years of experience in senior positions in the field of medical technology, preferably in an international setting.
• In-depth knowledge of relevant national and international medical device regulations, standards, and guidelines (e.g., MDR, FDA guidelines, GCP/ICH, ISO 14155).
• Proven track record of successfully leading and managing clinical trials from inception to completion.
• Leadership experience and excellent communication skills.
• Fluency in English required, German language knowledge desirable.

• Drive first-of-a kind innovation for high-growth, fast-paced, innovative global med-tech start-up.
• Collaborate in an active and synergetic team with a pleasant communication culture.
• Attractive remuneration package.
• Company HQ in the Freiburg “tri-border” region with cultural offerings and active, outdoor lifestyles.
• Company health management, Hansefit Membership.