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Senior Regulatory Affairs Consultant - MedTech

Capgemini Engineering
Skåne län
för 2 veckor sedan

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
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
  • 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.
  • A valid work permit for Sweden.

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.

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.

#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

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