CAPS Medical has developed a highly selective and minimally invasive Non-thermal Atmospheric Plasma (NTAP) device able to painlessly treat a wide range of solid tumors without impacting surrounding tissue. Working at CAPS Medical will enable you to grow your career and join a team of talented people, committed to making a difference in the way cancer is treated.
CAPS medical is seeking a talented Director of Regulatory and Clinical Affairs with a focus on research and development of complex multidisciplinary devices, to join our growing team and participate in the development of Non Thermal Plasma technology, with role growth opportunities. In this role you will take part in development and execution of the company’s clinical and regulatory strategy and goals . To research and define clinical applications support and involvement in R&D effort alongside bring-up and share effort in the execution of clinical studies and regulatory submissions.
o Take central role in executing Regulatory / Clinical Strategy, including
· Planning and execution of clinical trials and different clinical activities according toGCP and following company SOPs
· Writing and reviewing regulatory documents such as SOP, CER, validations etc
· Support product regulatory submission to FDA, and EMEA
· Preparation of clinical knowledge scientific documents
o Support activities from the scientific/medical point of view in strategic thinking,planning and execution including:
· Supporting the writing and review of marketing materials and white papers
· Contact and communication with leading physicians, KOLs and consultants
· Literature search and providing clinical publication supporting materials
· Active participation in scientific meetings / lectures / congresses.
o Support of R&D process of medical devices, including:
· Planning and execution of ex-vivo, in-vivo pre-clinical studies
· Take part in search and develop new clinical applications and Treatment's protocol establishment
· Data collection, analysis, and reporting
· Risk management process
· PhD / MSC in life sciences/ MD.
· At least 5 years’ experience in the medical device industry.
· Ability to operate according to applicable regulations and standards, such as QMS, GCP, etc.
· Regulatory/Clinical documents writing
· Proven hands on experience in the conduct ofclinical investigations and GCP compliance - benefit.
· Excellent self learningcapability
· High interpersonal skills
· Excellent teamwork skills
· Strategic thinking
· Fluent English.
To apply, please submit your CV to: