Specialist (m/f/d) Regulatory Affairs & Quality

The Opportunity

This position works out of our Munich location in the Laralab GmbH.

Location: Germany > München: Herzog-Heinrich-Straße 13.

Your Tasks

• Lead regulatory clearance for new AI products and modules, focused on CE and FDA regulatory pathways for medical device software
• Contribute to key regulatory areas such as technical documentation, clinical evaluation, and safety reports
• Lead risk management activities throughout the product lifecycle in accordance with ISO 14971, including hazard analysis, risk assessments, and risk-benefit evaluations
• Direct communication with responsible regulatory authorities (e.g., Notified Bodies, FDA, BfArM)
• Stay ahead of the fast‑paced evolution of global regulatory requirements and AI capabilities to ensure the compliance of our medical device software
• Reporting adverse events/incidents to the relevant regulatory authorities
• Supporting product recalls, safety notices, and field safety communications
• Participating in quality assurance activities (CAPAs, supplier evaluations, internal audit etc.)
• Support the continuous improvement and efficient operation of our Quality Management System in accordance with ISO 13485, EU MDR, and applicable FDA requirements
• Serving as a point of contact for internal business functions regarding inquiries related to Regulatory Compliance and Quality Systems

Qualifications

• Successfully completed degree in a scientific, technical, or medical field (preferably Biomedical Engineering, Medical Technology, Life Sciences, Regulatory Affairs, Software Engineering, Computer Science, or a related scientific or technical discipline)
• Professional experience in Regulatory Compliance, Regulatory Affairs, and/or Quality Management within a medical device company
• Experience with regulatory submissions and approval processes for medical device software (esp. CE and FDA)
• Knowledge of global laws, standards and regulations applicable to medical device software (e.g. MDR 2017/745; 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971, IEC 81001-5-1)
• Strong analytical skills, attention to detail, and organizational abilities
• Demonstrated ability to independently own tasks from start to finish proactively removing blockers and following through to completion
• Interest and understanding of AI technology and frameworks are a plus
• Excellent communication skills and a solution‑oriented mindset
• Ability to handle sensitive data with a high level of confidentiality and professionalism

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.