Clinical Research Scientist (Device, Ortho)

As a Clinical Research Scientist at Red Nucleus, you will play a crucial role in developing post-market clinical research strategies for orthopedic devices to meet global regulatory and post-market surveillance requirements. Your responsibilities will include: - Collaborating with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to devise post-market clinical evidence generation strategies aligned with EU Medical Device Regulations (EU MDR). You will facilitate clinical evidence reviews, document decisions and risks, and craft PMCF Plans. - Independently developing and crafting high-quality Post-market Clinical Follow-up (PMCF) plans and reports. You will also assist in creating clinical study protocols, registry plans, informed consents, and investigator brochures as necessary. - Reviewing summaries of clinical evidence and PMCF strategies in Technical Documentation to ensure accuracy and completeness. This involves assessing the Clinical Evaluation Plan, Clinical Evaluation Report (CEP), Post Market Surveillance Plan, and Periodic Safety Update Report (PSUR). - Establishing relationships with surgeons, hospitals, and research teams to gather input on study design, assess study feasibility, and identify study sites. You will work closely with the study core team to ensure project progress and effective issue communication. - Engaging in clinical scientific discussions with internal stakeholders to advocate for clinical and regulatory strategies and address evidence needs. You will contribute to interpreting and disseminating generated evidence through abstracts, manuscripts, Clinical Study Reports (CSR), and epidemiology study results. - Developing a comprehensive understanding of the orthopedic device product portfolio and the business requirements for clinical evidence to meet regulatory standards. To qualify for this role, you should have: - A Master's degree in Biological Science or a related discipline, coupled with a minimum of 4 years of experience in the medical device industry or healthcare sector. - Proficiency in technical writing, particularly in writing PMCF plans/reports. - Clinical expertise in the medical device domain and a proven track record in conducting clinical studies and registries, especially in orthopedics. - Strong project management skills with the ability to manage multiple projects concurrently and minimal supervision. - Excellent communication skills, including the ability to effectively interact with healthcare professionals (HCPs), hospital staff, and other stakeholders.,