Senior Regulatory Affairs Consultant - Malmö

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 technology, as Capgemini Engineering Sweden is certified under ISO 13485, but we also work with the pharmaceutical industry.
We offer a great atmosphere and present managers who have as their main task to facilitate and work closely with the consultants, which is all in line with Capgemini Engineering's values - Ambition & Care. For us, community is important in addition to professional development, and we work to promote participation by continuously arranging lunches, breakfasts, After Works, sports events and more.
In the role as Senior Regulatory Affairs Consultant, you will work in a variety of Life Science projects. You will handle challenging and varied tasks that requires you to be results- and client-oriented and to display excellent interpersonal skills. At the same time, you will have the opportunity to actively participate in the company’s continued development. You will be part of the Life Science Team, consisting of highly skilled and motivated colleagues, and work in a dynamic and stimulating environment.
Your role
Working operationally and strategically with Regulatory Affairs, both at a local and global level.
In projects, provide regulatory expertise and guidance on procedural and documentation requirements.
Be the regulatory advisor for new product registrations/variations/renewals and launch preparations.
Identify potential regulatory risks and propose options to mitigate these.
Regular communication with health authorities and regulatory intelligence.
Function as the Regulatory expert in in-house projects at Capgemini Engineering.



Your profile
MSc in chemistry, pharmacy or engineering.
At least 5 years experience in Regulatory Affairs from the Life Sciences industry.
Excellent understanding of registration procedures and requirements as well as product life cycle management from a regulatory affairs perspective.
Strong project management skills.
Organized and analytical mindset with a good sense of details while still keeping an eye on the overall goal of the project.
Ability to work to deadlines and solving issues in a pragmatic and proactive way.
Excellent written and verbal communication skills.
Fluent in Swedish and English language.