Quality & Regulatory Affairs Manager, Software as a Medical Device

Project overview

You will be involved in the development and maintenance of a Healthcare Quality Management System that supports multiple medical software products delivered to international markets. The project focuses on aligning software engineering practices with medical device regulations and quality standards.

Position overview

We are looking for a Quality Systems Specialist who will contribute to building and maintaining quality systems for medical software products classified as Software as a Medical Device. You will work on regulatory compliant digital health solutions intended for the EU and US markets, focusing on quality processes, documentation, audits, and continuous improvement across the full software lifecycle.

Responsibilities

• Maintain and support the Healthcare Quality Management System and its ongoing certification activities.

• Support preparation for and participation in external audits, including evidence collection and audit coordination.

• Provide quality support to medical software projects throughout planning, development, release, and maintenance phases.

• Prepare and execute internal audits, including audit planning, documentation, reporting, and follow up actions.

• Support coordination and tracking of corrective and preventive actions.

• Collaborate with engineering, legal, compliance, and other internal teams on quality and regulatory topics.

• Participate in customer audits and supplier evaluations within the scope of assigned projects.

• Contribute to continuous improvement initiatives and systemic quality enhancements.

• Support validation activities for quality management and documentation tools.

• Promote quality awareness by delivering internal workshops and training sessions.

Requirements

• At least three years of experience working with medical device quality systems.

• Practical experience with ISO 13485 and ISO 14971.

• A degree in engineering, medical technology, life sciences, or a comparable field.

• Experience working with structured documentation and regulated processes.

• Ability to work independently while coordinating effectively with multiple stakeholders.

• Strong analytical, documentation, and written communication skills.

• Professional working proficiency in English.

• Interest in developing skills in regulatory affairs for medical software.

Nice to have

• Experience participating in or conducting audits.

• Exposure to IEC 62304 or other medical software lifecycle standards.

• Understanding of Agile software development practices.

• Initial experience with EU or US medical device regulatory frameworks.

What We Offer:

• Vacation days: Up to 26 business days per year.

• 10 illness/special days off per year (fully paid, no medical papers needed) for all contract types

• Health and life insurance (Luxmed)

• MyBenefit platform with Multisport option

• Internal psychological support service

• English language classes from the first working day

• Access to external learning platforms: O’Reilly, LinkedIn Learning, Udemy, and a wide catalog of diverse internal training

• Flexible workplace: work from the office, from home, or choose a hybrid option

• Tech Skills Mentoring Program

• Opportunities to develop as a public speaker, mentor, or technical interviewer

• Fully paid idle (bench) when not involved in a project

• Certification reimbursement (AWS, GCP, Microsoft, etc.)