Regulatory Affairs Manager, IVDR

As a Regulatory Affairs Manager, you own the path that takes our software from a validated product to a CE-marked in vitro diagnostic — and keep us audit-ready every day in between.

You will lead technical documentation, manage interactions with notified bodies, and partner with clinical and engineering teams to ensure everything we ship meets IVDR requirements. This is a fully remote role open to candidates based in the EU.

Responsibilities

• Lead IVDR technical documentation and submissions for our diagnostic software.
• Manage relationships and correspondence with notified bodies and competent authorities.
• Maintain and continuously improve our ISO 13485 quality management system.
• Coordinate risk management, change control, and post-market surveillance processes.
• Advise product and engineering teams on regulatory implications of new features.

Required qualifications

• 4+ years of regulatory affairs experience with medical devices or IVDs.
• Working knowledge of IVDR (EU 2017/746) and ISO 13485.
• Experience assembling technical documentation and managing notified body interactions.
• Exceptional organization, written communication, and attention to detail.
• Ability to translate regulatory requirements into practical guidance for technical teams.

Preferred qualifications

• Experience with software as a medical device (SaMD) and IEC 62304.
• Familiarity with AI/ML-based medical devices and emerging guidance.
• Experience supporting submissions in additional markets (FDA, UKCA).

For this role, we value precision, calm under audit pressure, and the ability to make complex regulation legible to the people building the product.

Our perks

Fully remote within the EU, flexible schedules, open paid time off, private health insurance, a learning budget, and equity for every team member.

Digital Pathology Solutions is an equal opportunity employer. We make reasonable accommodations for candidates with disabilities and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, or any other category protected by applicable law.