Regulatory Affairs Specialist

Location: Remote / Hybrid / On-site (Zagreb, Croatia)
Job Type: Full-Time

Become part of the team building medical imaging software that helps clinicians make better decisions. We are looking for an experienced Regulatory Affairs Specialist to support regulatory and quality assurance activities for our AI-based radiology software products.

You will work closely with clinical, engineering, and leadership teams to support FDA and EU MDR certification pathways, maintain and improve compliance processes, and help ensure our products meet the highest standards for safety, performance, and regulatory compliance.

Key Responsibilities

• Support regulatory strategy, submissions, and certification activities for FDA and EU MDR pathways

• Maintain and improve quality management and compliance processes across the company

• Prepare and maintain technical, regulatory, and clinical documentation for medical software products

• Coordinate activities related to risk management, clinical evaluation, usability, and post-market monitoring

• Support audits and collaborate with external consultants, notified bodies, and certification partners

• Work closely with engineering and clinical teams to support compliant software development and documentation processes 

Requirements

• 4+ years of experience in Regulatory Affairs, Quality Assurance, or related roles within healthcare, medical technology, or regulated software environments 

• Experience with FDA 510(k) or EU MDR regulatory pathways

• Experience supporting audits, certification activities, regulatory submissions, or quality management processes

• Ability to independently manage documentation and compliance activities in a structured and detail-oriented manner

• Strong communication and organizational skills

• Professional proficiency in English

Nice to Have

• Degree in a relevant scientific, healthcare, engineering, or technical field 

• Familiarity with relevant medical device and healthcare software standards and frameworks (e.g. ISO 13485, IEC 62304, ISO 14971, IEC 62366, and related standards)

• Familiarity with clinical study design, data collection methodologies, and statistical analysis approaches in healthcare 

• Experience working in startups or fast-growing healthcare technology companies

Why Should You Join?

• Be part of an innovative early-stage startup with a mission to improve healthcare

• Competitive salary and career growth opportunities

• Work on challenging and impactful medical software solutions

• A collaborative and flexible work environment

How to Apply

Send your CV to careers@medaibravo.com