Senior Consultant – Regulatory Affairs, Medical Devices, Software, AI

This is a fully remote position, open to applicants in Germany.

📋 Description

• Formulate strategies for obtaining regulatory approvals for medical devices and in vitro diagnostics (IVDs) across the EU, USA, and other global markets.

• Assist in the approval process of medical devices, including software categorized as a medical device (SaMD / SiMD) and functionalities based on AI.

• Convert regulatory requirements into actionable steps for Regulatory Affairs, Development, Quality Management, and Product Management teams.

• Prepare and evaluate technical documentation and regulatory submission files.

• Analyze products, modifications, and new technologies in relation to qualification, classification, regulatory pathways, and compliance requirements.

• Engage with notified bodies, regulatory authorities, and other relevant stakeholders.

• Provide guidance to clients throughout complex coordination and consultation processes.

• Take independent ownership of consulting projects and ensure their successful execution.

⛳️ Requirements

• A completed degree in a relevant field such as natural sciences, engineering, medical, or technical disciplines.

• A minimum of five years' experience in Regulatory Affairs within the medical device sector.

• Familiarity with regulatory standards under the MDR and FDA regulations.

• An understanding of software development, documentation, and regulation processes.

• A keen interest in AI technologies and a willingness to explore their implications in medical devices and associated regulatory challenges.

• Knowledge of ISO 13485, ISO 14971, and IEC 62304 standards.

• Proficiency in both written and spoken German and English.

• Availability for occasional travel related to client projects.

🏝️ Benefits

• A progressive work environment that encourages initiative and provides the freedom to implement change.

• A positive team culture with a strong emphasis on collaboration.

• Encouragement and support for your professional and personal growth.

• Flexible working options without core hours.

• Opportunities for remote work or positions at our locations in Konstanz or Frankfurt.

• JobRad bicycle leasing program.

• Participation in the Hansefit corporate fitness initiative.

• Two team-building events held each year.

• The chance to work from a different location for a limited time (workation).