Clinical Scientist

🔥 15 hours ago

🇩🇪 Germany – Remote

💵 $105.9k - $179.4k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 0%

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Intuitive

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1995

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care.

📋 Description

• Report to the Manager, Medical Sciences • Develop strategies and author Clinical Evaluation Plans and Clinical Evaluation Reports under EU MDR • Support CE Mark submissions, Declaration of Conformity, EU market clearance, re-certification, and indication/labeling changes • Develop responses to regulatory authority requests and questions • Collaborate with engineering, product development, regulatory, and post-market surveillance teams • Conduct and support comprehensive scientific literature searches • Review, interpret, summarize, and critically appraise scientific literature and clinical data • Support risk assessments through collection and summarization of primary data • Provide product guidance to clinical librarians • Proofread, edit, format, integrate comments, and complete documentation approvals • Manage CEP/CER timelines using project management tools • Serve as subject-matter expert or functional representative for R&D development activities • Review risk documentation and product labeling and ensure updates are implemented • Provide clinical guidance for new product development for CE Mark purposes • Create clinical content for investigator brochures, manuscripts, abstracts, presentations, and posters • Support clinical study protocol and Clinical Study Report development and writing • Ensure compliance with corporate SOPs and regulatory requirements

🎯 Requirements

• Previous experience applying in-depth therapeutic and device knowledge to Clinical Evaluation Plans and Reports • Minimum of 2 years of medical writing experience • Experience conducting literature searches and reviewing/appraising scientific data • Strong scientific and technical writing skills • Excellent critical thinking and analytical skills • High attention to detail and accuracy • Ability to work effectively with cross-functional teams • Ability to manage multiple projects across numerous surgical disciplines • Strong protocol development, regulatory submission writing, and clinical evaluation report writing experience • Ability to learn different surgical specialties and medical products/procedures • MD, PhD or M.S. degree in a scientific field • Knowledge of applicable regulations and standards, including EU MDR, GCP, and US/OUS guidelines • Minimum of 0–2 years of CER writing experience in the medical device industry preferred • May be required to show current proof of vaccination against certain diseases, including COVID-19 • U.S. export-control requirements may apply to certain candidates

🏖️ Benefits

• Remote work; employees come onsite when requested by the leader • Incentives • Benefits • Equity • Equal employment opportunities • Consideration under fair chance laws