Senior Quality and Regulatory Consultants within Medical Devices to Capgemi

Are you passionate about and experienced in quality management and regulatory affairs related to development of medical devices? Join us and get the future you want! Capgemini Engineering is in a global leading position within innovation, development and engineering. Together with our partners we are facing exciting challenges whilst creating the future. Our team is taking the efficiency, quality and compliance of our partners to the next level in order to develop smarter products and become an even stronger player within the life science industry. Our offer By offering exciting opportunities of career development you can get the future you want. Capgemini Engineering offers you a work environment that is characterized by innovation. As a consultant at Capgemini Engineering, you are part of something bigger. We deliver, together with our global centers of expertise, solutions for both large global customers and smaller local start-ups. We are driven by meeting the customer's needs and generating added value. In the Life Science Team in Malmö, we work mainly with medical devices, as Capgemini Engineering Sweden is certified under ISO 13485. Your Role As a consultant in our life science team, you will be leading quality management in development projects related to medical devices. In many of our client assignments, our consultants work in teams provided to the client by Capgemini Engineering – but in close collaboration with employees of the client. You may be working in accordance with Capgemini Engineering’s processes for design control and project management as well as with applicable standards, legislations and client-specific processes in order to ensure quality assured activities and documentation throughout the design and development process. You as an individual are self-driven, prestige-less and a team-player. We expect that you will lead others and that you are interested in taking the driver’s seat with regards to your own development as well as your colleagues. You find the consultant role interesting and thrive in a varied environment where changes sometimes take place with abrupt changes. Your Profile You have: - A degree in engineering, a Master of Science, pharmacy degree or similar, - Long experience within development (design control) and regulatory submission of medical devices (SaMD/digital therapeutics experience is particularly meritorious), - Knowledge of and/or experience of working accordance with: MDR, 21 CFR 800-series, ISO 13485, ISO 14971, IEC 62366 and/or IEC 62304, and - The ability to communicate fluently in spoken and written English. You as a person are: - Curious and motivated by exciting challenges, - A person who takes initiatives, is flexible and thrives in a dynamic environment, - A person who finds it easy to cooperate and communicate with different groups pf people, - Genuinely interested in technology and problem solving, and - Driven by challenges and personal development. About Us Capgemini Engineering is one of the world’s leading consultant companies within R&D. We are part of Capgemini Group with around 270 000 employees globally. In Scandinavia, our main areas of business are Industry, Automotive, Life Science and the Public Sector. Together with our global centers of expertise, we deliver solutions to both global clients and local start-up companies. Based on the need of the client, we provide competence, complete project teams and services. We always adapt our solutions and services to the client’s organization and challenges. Our organization is characterized by a team spirit atmosphere and leaders whose main focus is to support the consultants in their projects – all in line with our core values Ambition & Care. We actively work to promote participation by regularly organize team breakfasts and lunches, after works, sport events and other fun activities! We care about our employees, and to us it is important that all our employees have a close connection to their teams as well as team managers. Application and Contact Interviews are ongoing. If you have questions or want more information, please contact our Talent Acquisition Partner Martin Svensson at martin.svensson@capgemini.com We kindly refrain from contact with advertises and employment agencies in the recruitment process. Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2020 global revenues of €16 billion. Get the Future You Want | www.capgemini.com