We are looking for a Senior Consultant within SaMD and Digital Health to our Compliance, Quality & Regulatory team in Malmö. In this role you will work towards diverse goals based on the client’s specific needs. You may work as a subject matter expert or strategic advisor, with the key purpose to drive and supporting our clients in achieving their objectives with regards to quality and compliance. You may also be part of our legal manufacturing organization that focuses on design and development of SaMD (up to class IIb).
You will collaborate with medical device clients to deliver patient-focused, compliant, and efficient solutions. Your expertise will be crucial in bridging between the technical and regulatory requirements, ensuring that SaMD development meets stringent quality standards from development to product lifecycle management.
Required Experience
• A degree in engineering, a master of science, pharmacy degree or similar
• Long experience of working in accordance with IEC 62304 and IEC 82304
• Knowledge of and/or experience of working accordance with: ISO 13485, ISO 14971 and IEC 62366
• Experience from regulatory submission of SaMD to regulatory authorities (EU and US)
• The ability to communicate fluently in spoken and written English
Meritorious
• Knowledge of the EU AI Act and ISO 42001
• Knowledge of validation of AI systems/software
• Knowledge of and/or experience in ISO 27000 series
• Experience from regulatory submission of SaMD to regulatory authorities (other markets)
You as a person:
You are a highly organized professional with proven experience in SaMD, demonstrating exceptional skills in coordinating and advising. You are curious and eager to learn new skills and explore new technologies. You must be easy to collaborate with, you bring a positive energy and dynamic approach to every challenge. Your communication skills and service-minded attitude make you an invaluable team player who is not afraid of problems but instead sees them as opportunities for innovative solutions. At Capgemini Engineering, we value excellence, care, responsibility, dynamism, and innovation. We offer diverse projects, career development opportunities, and a collaborative environment where your contributions make a difference in advancing healthcare and technology.
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