About Overture LifeToday, fertility clinics help people make babies. But one of the bottlenecks of fertility is the embryology lab. It is an extremely laborious manual process, as embryos are made by hand. At Overture we are automating the embryology lab in order to make IVF more available, affordable and reliable. Overture is a global start up with offices in US, UK and Spain which aims to revolutionize embryology.As a company, we want to democratize access to fertility treatment benefits and give everyone the opportunity to bring home healthy babies. Our close-knit team cultivates an environment of creativity, innovation, rapid iteration and collaboration with both scientific, engineering and operations teams.The environment is dynamic, fast-paced and requires a self-starter attitude.Job briefWe are seeking a highly skilled and motivated Clinical & Regulatory Affairs to join our team and manage clinical trials of Overture Life's devices in all countries, especially in Spain and in the U.S.Main tasks- Strategic translation of business objectives into clinical requirements for clinical trials.- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and reports and data presentation in publications- Manage the process of screening, qualifying, and selecting and contracting with investigators and sites required for conduct of clinical trials.- Develop, maintain and expand collaborations with outside clinical investigators, researchers and KOL to facilitate the optimum performance of clinical development programs.- Develop SOPs and work instructions to assure internal files and clinical study files conform to Good Clinical Practice regulations and standards.- Obtain necessary clinical trial approvals from IRBs/ECs and regulatory bodies such as the FDA and Competent Authorities.- Oversee clinical data collection, trial monitoring and auditing according to GCP guidelines and Standard Operating Procedures- Ensure studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.- Represent the clinical trials management during clinical trial case review with physicians, hospital staff and coordinators- Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.- Prepare required documentation for regulatory agencies- Manage resources in the Clinical Affairs area, identifying the needs or new requirements.- Ensure and follow up the progress, risks and opportunities of the project.Requirements- Graduate Degree or higher in Life Sciences or related disciplines- 3 years of experience implementing new clinical trial projects, preferably within the MedTech industry.- Broad cross-disciplinary knowledge of clinical research- Extensive knowledge and comprehensive understanding of applicable GCP, ICH guidelines and CE mark or any applicable international regulations- Strong organizational and commercial skills.- Solid literature research skills- Fluent in English and Spanish. Excellent communication and computer skills.Nice to have- Experience in working in the development of diagnostic product- Knowledge and experience in relevant regulations & directives for medical devices- Familiar with Spanish and European regulatory institutions and Ethical committees approvals for Clinical Affairs.- Experience in performing systematic literature reviews and clinical evaluations- Good understanding of Design Control in accordance with ISO 13485#J-18808-Ljbffr
