Role Description Our mission is to prevent vision loss and ultimately blindness by developing AI software that assists eye doctors in therapy planning for their patients. We use computer vision deep learning models (AI) trained on thousands of cases and millions of images to predict disease progression, individualize therapy and improve outcomes. The decision support algorithm targets widespread eye diseases like Age-related Macular Degeneration (AMD, 7.5mio affected in Germany alone). What you'll do - Clinical Evaluation (core assignment): Lead the preparation, update, and quality control of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in accordance with Regulation (EU) 2017/745 (EU MDR), Article 61 and Annex XIV, Part A, following the methodological principles of MEDDEV 2.7/1 rev. 4. - Literature search & appraisal: Design and document systematic literature searches, appraise clinical evidence, and produce a traceable, audit-ready evidence synthesis suitable for review by our Notified Body. - Post-market clinical follow-up: Support PMCF planning and reporting (Annex XIV, Part B) and, where applicable, the SSCP. - Scientific publications (secondary): Translate clinical and technical data into scientific manuscripts, research summaries, and white papers for peer-reviewed journals and other channels. - Cross-functional collaboration: Act as the link between our clinical, R&D, and regulatory teams, ensuring clinical evidence is accurately reflected in the technical documentation. - Documentation standards: Establish project-specific style guidelines and maintain high quality standards, ensuring compliance with relevant regulatory requirements. Qualifications - Suitably qualified evaluator: Meet the competency expectations for clinical evaluators, including expertise in the diagnosis and management of the target indication, and qualifications are documentable (e.g., CV) for Notified Body review in line with EU MDR Annex XIV and MEDDEV 2.7/1 rev. 4. - Working style: Reliable freelancer mindset with strong project management, ability to work with cross-functional stakeholders (Clinical, RA/QA, R&D) and meet timelines. - Publication support: Demonstrated experience drafting and editing scientific manuscripts/abstracts/posters and other clinical/scientific communications in English. - Medical device experience (SaMD/digital health preferred): Proven track record (5+ years) in medical writing for medical devices (ideally SaMD/AI) with strong understanding of intended purpose/claims and how they map to clinical evidence. - Clinical evidence synthesis: Ability to plan and execute (or manage) systematic literature searches, critically appraise clinical data, and synthesize evidence for safety, performance, and clinical benefit; traceable, audit-ready documentation and referencing. - EU MDR clinical evaluation expertise: Hands-on experience authoring and/or updating Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance with Regulation (EU) 2017/745 (EU MDR), incl. MEDDEV 2.7/1 rev. 4 principles, and strong familiarity with MDR requirements for clinical evaluation and clinical evidence (e.g., Annex XIV Part A and Part B; relevant links to Annex II/III where applicable). Requirements - Your nice-to-haves: - Advanced degree (Master/PhD) in a scientific or health-related field. - Experience in ophthalmology, medical AI, or digital health. - Proficiency in German (C1). Benefits - Project-based collaboration - Flexible, fully remote setup - Potential for long-term partnership on upcoming clinical and regulatory projects - Startup culture & a great, international team - High personal responsibility for your project & fast personal growth - Direct impact on improving quality of life for our end users (patients) Company Description deepeye is a fast-growing medical device software startup based in Munich, with an international rockstar team spread mostly across Germany.

Role Description Under the direction of The Administrator, Coding & Clinical Documentation Improvement and Patient Access, the Manager of Clinical Documentation Integrity (CDI) and DRG Denials is responsible for the day-to-day operation of the CDI department and DRG Denials appeals process. The Manager will: - Develop, implement, and evaluate processes, policies, and procedures related to clinical documentation improvement for all Garnet Health hospitals. - Lead CDI functions and oversee the day-to-day work in the department. - Ensure that reviews of the patient’s medical data are conducted to assess appropriateness and medical necessity for admission and continued stay. - Facilitate improvement in the overall quality, completeness, and accuracy of medical record documentation. - Evaluate denials and work closely with the outcomes manager and coding denial coordinator to oversee and write compelling, factual arguments when warranted to the third parties denying claims. Join the Garnet Health team and let your excellence shine. Compensation for the role is $80,106-$100,133 USD per year. Fully remote from the following states: Pennsylvania; Florida; South Carolina; North Carolina; Texas. Garnet Health System provides a compensation range to comply with the New York State law on Salary Transparency in Job Advertisements. The range or contractual rate listed does not include bonuses/incentives, differential pay, or other forms of compensation or benefits. When determining a team member’s compensation and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget, and internal equity). Qualifications - Bachelor's Degree in Nursing - Minimum of 3-5 years of progressive experience in an acute care hospital (larger than 100 beds) - Minimum of five years of experience in the CDI industry - Strong knowledge of ICD 10 diagnosis coding, CPT Coding guidelines, and DRG-based reimbursement knowledge - Exceptional ability to communicate effectively with physicians and other clinical professional staff - Knowledge of DRG and Coding appeal process Requirements - Certified Clinical Documentation Specialist (CCDS) credentialed within 6 months - Current license to practice as a Registered Professional Nurse in New York State required - Travel to multiple facilities is required Working Conditions - Environmental Demands and Exposure to Hazards: Works in a clean, well-lighted, heated, or ventilated facility. No routine exposure to hazards. - Physical Demands: Demonstrates physical and functional ability to perform full anatomical range of motion to accomplish tasks. Evidence of visual and aural acuity and finger and hand dexterity to operate computer and office equipment. Can withstand long periods of sitting, standing, and/or constant walking. Ability to lift 10 lbs. - Mental Demands: Ability to foster collaborative relationships, work well under pressure, organize and synthesize new information, and prioritize tasks. Possesses critical thinking, analytical skills, and flexibility. Ability to multi-task. Required detailed attention to work in an environment where interruptions cannot be controlled. Demonstrates sensitivity to customer needs and expectations. May be subject to irregular hours including evenings or potentially weekends to participate in operational and community events as necessary. Workplace Type Hybrid

• Responsible for performing concurrent reviews of patient records to ensure complete, accurate, and specific clinical documentation. • Should have a comprehensive understanding of ICD and CPT Coding Guidelines. • Responsible for clarifying conflicting, incomplete, or imprecise documentation by actively seeking answers and actively educating providers. • Work to continuously improve clinical documentation to best reflect the care provided and corresponding reimbursement. • Responsible for improving the overall quality and completeness of clinical documentation. • Facilitate modifications to clinical documentation through extensive concurrent interaction with physicians, nursing staff, other patient caregivers, and Coding staff to support that appropriate reimbursement, clinical severity of illness, and risk of mortality is captured for the level of service rendered to all patients. • Supports timely, accurate and complete documentation of clinical information used for measuring and reporting physician and practice outcomes. • Educates all members of the patient care team on an ongoing basis.

• The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. • Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonization (ICH) and other regulatory guidelines, and individual company document standards. • Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents. • Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents). • Author documents per client specifications, templates, style guides, and other guidance documents. • Author documents per regulatory authority guidelines and requirements. • Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result. • Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work. • Manage budget for a low complexity project, including all contributors (writers, editors). • Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus. • Maintain collaborative, proactive, and effective communication with both clients and internal teams. • Lead project-related meetings and teleconferences. • Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements.