CAPGEMINI ENGINEERING
Senior consultant within SaMD and Digital Health
Om jobbet
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.
Your Role
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.
Your profile
• 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 skills
• 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.
What we believe you will enjoy about working here
• We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance.
• At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
• We support your personal development and offer an education library with more than 250 000 (!) courses and educations and certifications.
Join us and get the future you want!
#LI-MS8
About Capgemini
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion. Get The Future You Want | www.capgemini.com
Your Role
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.
Your profile
• 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 skills
• 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.
What we believe you will enjoy about working here
• We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance.
• At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
• We support your personal development and offer an education library with more than 250 000 (!) courses and educations and certifications.
Join us and get the future you want!
#LI-MS8
About Capgemini
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion. Get The Future You Want | www.capgemini.com
CAPGEMINI ENGINEERING
FöretagCAPGEMINI ENGINEERING
