Remote Regulatory & Clinical Data Ops Leader

Retinai Medical; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Supportive work environment

Opportunities for professional growth

Occasional travel to HQ in Switzerland

Job summary

Retinai Medical is seeking a US-based Regulatory Affairs & Clinical Data Operations Manager to lead regulatory compliance efforts and manage robust healthcare data operations. This remote role also serves as a Clinical Research Associate (CRA), supporting clinical studies across the US.

This position blends regulatory expertise with clinical data management to ensure quality compliance and integrity of submissions and healthcare datasets, with opportunities for career advancement as the organization grows.

Qualifications

• Minimum of 1 year of experience as a Clinical Research Associate (CRA).
• 2–5 years of regulatory experience including FDA submissions, MDR, and ISO standards.
• Proficiency in managing EMR data with familiarity in the US healthcare system.

Responsibilities

• Prepare and submit FDA 510(k), De Novo, and Pre-Submission documentation.
• Oversee regulatory compliance activities including SOC2/HITRUST and HIPAA.
• Support US reimbursement strategies and manage CPT codes.

Skills

Regulatory compliance

Clinical data management

Data management tools (e.g. SQL, Python, R)

Project management

Communication skills

Education

Bachelor’s or Master’s degree in Life Sciences, Health Informatics, Regulatory Affairs, Data Science, or related field

Tools

SQL

Python

R

Power BI

Tableau

Job description

Retinai Medical is seeking a US-based Regulatory Affairs & Clinical Data Operations Manager to lead regulatory compliance efforts and manage robust healthcare data operations. This remote role also serves as a Clinical Research Associate (CRA), supporting clinical studies across the US.

This position blends regulatory expertise with clinical data management to ensure quality compliance and integrity of submissions and healthcare datasets, with opportunities for career advancement as the organization grows.