Clinical Scientist

This is a fully remote position, open to applicants in Germany.

📋 Description

• Report to the Manager of Medical Sciences.

• Formulate strategies and draft Clinical Evaluation Plans and Clinical Evaluation Reports in accordance with EU MDR.

• Assist with CE Mark submissions, Declaration of Conformity, EU market clearance, re-certification, and changes in indications/labeling.

• Develop responses to inquiries and requests from regulatory authorities.

• Collaborate with teams in engineering, product development, regulatory affairs, and post-market surveillance.

• Perform and assist in extensive scientific literature searches.

• Review, interpret, summarize, and critically evaluate scientific literature and clinical data.

• Support risk assessments by gathering and summarizing primary data.

• Offer product guidance to clinical librarians.

• Proofread, edit, format, integrate feedback, and finalize documentation approvals.

• Oversee CEP/CER timelines utilizing project management tools.

• Act as a subject-matter expert or functional representative for R&D development initiatives.

• Examine risk documentation and product labeling to ensure that updates are executed.

• Provide clinical guidance for new product development aimed at CE Mark approval.

• Generate clinical content for investigator brochures, manuscripts, abstracts, presentations, and posters.

• Assist in the development and writing of clinical study protocols and Clinical Study Reports.

• Ensure adherence to corporate SOPs and regulatory standards.

⛳️ Requirements

• Prior experience utilizing deep therapeutic and device knowledge in Clinical Evaluation Plans and Reports.

• At least 2 years of experience in medical writing.

• Experience in conducting literature searches and evaluating scientific data.

• Strong abilities in scientific and technical writing.

• Excellent critical thinking and analytical capabilities.

• High level of attention to detail and precision.

• Capacity to work efficiently with cross-functional teams.

• Ability to manage multiple projects across various surgical disciplines.

• Robust experience in protocol development, regulatory submission writing, and clinical evaluation report writing.

• Willingness to learn about diverse surgical specialties and medical products/procedures.

• MD, PhD, or M.S. degree in a scientific discipline.

• Familiarity with relevant regulations and standards, including EU MDR, GCP, and US/OUS guidelines.

• Preferred to have 0–2 years of experience writing CERs in the medical device sector.

• May need to provide current proof of vaccination against specific diseases, including COVID-19.

• U.S. export-control regulations may apply to certain applicants.

🏝️ Benefits

• Remote work; employees are required to come onsite only when requested by leadership.

• Incentives.

• Comprehensive benefits.

• Equity opportunities.

• Equal employment opportunities.

• Consideration in accordance with fair chance laws.