Regulatory & Clinical Data Operations Specialist (Full time - Remote U.S.), RetinAI Medical, NJ, US

About Us

Ikerian AG (formerly RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland. Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening and monitoring. Join our diverse team of entrepreneurs, developers, researchers, and commercial experts who are collectively shaping the future of healthcare.

We are seeking a US-based Regulatory Affairs & Clinical Data Operations Manager to lead regulatory compliance efforts and manage robust healthcare data operations. This role will also serve as our Clinical Research Associate (CRA), supporting the execution of clinical studies at various sites across the US.

This dual-focus position blends regulatory expertise with clinical data management, ensuring the quality, compliance, and integrity of both regulatory submissions and healthcare datasets. As our organization grows, this role will evolve into more specialized functions, offering clear opportunities for career advancement.

Key responsibilities:

Regulatory Compliance

• Prepare and submit FDA 510(k), De Novo, Breakthrough, and Pre-Submission documentation, managing all aspects of CDRH and related filings.
• Oversee regulatory compliance activities including SOC2/HITRUST, HIPAA, and future certifications such as MDSAP.
• Support US reimbursement strategies, including engagement with payers and management of CPT codes and reimbursement processes.
• Ensure compliance with FDA QSR - 21 CFR Part 820, ISO 13485 QMS, ISO 14971 risk management, and MDR requirements.
• Manage internal and external audits, ensuring readiness and documentation compliance.

Data Management & Compliance

• Serve as CRA and support the conduct of clinical studies at various US sites.
• Manage healthcare datasets, including Electronic Medical Records (EMR), clinical databases, and research data.
• Develop and maintain data management processes to ensure high data quality, compliance, and analysis-readiness.
• Implement and oversee secure, compliant data pipelines and documentation, including data dictionaries, SOPs, and audit trails.
• Collaborate closely with Research, Clinical, Product Development, and Commercial teams to align data strategies with project goals.

Project Management & Collaboration

• Coordinate cross-functional teams to promote effective communication and timely project execution.
• Apply project management methodologies to ensure regulatory and data-related initiatives are completed efficiently.
• Maintain detailed documentation and support continuous improvement efforts to enhance operational efficiency and compliance.