Head of QRA - Full Time - CH

RetinAI Medical seeks a Head of QRA to lead global regulatory compliance and quality management for its AI-driven medical device portfolio in Bern, Switzerland.

This position is responsible for steering the QRA department's transition from a startup phase to a mature subsidiary operation following the acquisition by EssilorLuxottica. The role acts as a strategic advisor to internal R&D teams and global partners, ensuring operational excellence and adherence to worldwide regulatory standards while supporting the expansion of the product lineup.

Responsibilities

• Direct and develop a distributed global QRA team, fostering a culture of accountability, structured objectives, and continuous learning.
• Serve as the legally designated Person Responsible for Regulatory Compliance (PRRC) under EU MDR, maintaining technical documentation, overseeing post-market surveillance, and managing vigilance reporting.
• Create and implement comprehensive global regulatory strategies, prioritizing swift market entry through FDA submissions and CE-MDR compliance.
• Oversee and expand a high-caliber Quality Management System (QMS) to maintain readiness for ISO 13485 and MDSAP audits.
• Represent the organization during internal reviews, Notified Body assessments, partner evaluations, and health authority inspections to sustain corporate certifications.
• Collaborate closely with R&D to embed design controls, risk management, and software lifecycle processes into early development phases.
• Work with IT and Security teams to uphold data privacy standards (GDPR, HIPAA) and align quality processes with evolving cybersecurity requirements.
• Convert market insights and regulatory shifts into actionable compliance plans that integrate customer needs and health authority expectations into the product lifecycle.

Requirements

• University degree in Life Sciences, Biomedical Engineering, Law, or a related scientific field.
• At least 10 years of experience leading, managing, and mentoring cross-functional quality and regulatory teams.
• 8-10 years of dedicated experience in medical device Quality and Regulatory Affairs, with a focus on Software as a Medical Device (SaMD).
• Proven experience as a PRRC, including managing complex technical files for EU MDR and FDA submissions.
• Expert knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971, and FDA 21 CFR Part 820.
• Fluent English communication skills, both verbal and written.
• Strong analytical and problem-solving skills with attention to process detail, operational efficiency, and structural quality.
• Entrepreneurial and collaborative mindset with team-building and conflict-resolution capabilities.
• Ability to work independently as a leader.
• Availability to work during Central European Time (CET) business hours with regular physical presence at the Bern headquarters.

Nice to have

• A PhD or MBA is considered a strong asset.
• Formal Lead Auditor certification is highly valued.

What the company offers

• Opportunity to join a global team driving healthcare innovation.
• Competitive salary in a supportive work environment that promotes work-life balance.
• Professional growth and development opportunities in an international setting.
• A collaborative and inclusive culture that is central to the company's values.
• Occasional travel to the Swiss headquarters to engage with core operations and company culture.

About the company

RetinAI Medical is a rapidly expanding medical device software company based in Bern, Switzerland. The organization focuses on enabling better healthcare decisions through AI and data management solutions for disease screening and monitoring. The team comprises entrepreneurs, developers, researchers, and commercial experts.

• Fast-growing medical device software company.
• Mission-driven: enabling right decisions sooner in healthcare.
• Diverse team of entrepreneurs, developers, researchers, and commercial experts.
• Collaborative and inclusive culture.
• Supportive work environment promoting work-life balance.

How to apply

Application language: English