Head of Medical Devices Reg Strategy (JR004134) Uppsala, Sweden
At Galderma we’re unique and we embrace difference.
Whether it’s the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make – working here isn’t like anywhere else.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Galderma is looking for a Head of Medical Devices Reg Strategy to be based on our Uppsala site.
As Head of Medical Devices Reg Strategy, you will be in a global role responsible for setting strategy and driving the registration and maintenance of Galderma's portfolio of Medical Device in accordance with regulatory requirements and international quality standards. You will head the Medical Devices Regulatory Team of around 20 people, including 3 team leaders and work closely with main stakeholders including Aesthetics Business Unit, Operations, R&D, Medical Affairs and Commercial.
Key Tasks
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Lead the team working on Regulatory Affairs activities for the Company portfolio of Medical Device products.
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Create and drive strategies for new marketing applications worldwide.
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Secure compliance by adequate and timely assessment and implementation of new regulatory requirements worldwide, including assessing the regulatory impact of manufacturing and other improvements/changes to Galderma’s processes and where necessary notify authorities.
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Provide regulatory guidance in general to projects and organization.
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Guide and drive regulatory assessment of new opportunities (internal R&D candidates of Business Development external opportunities)
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Represent Global Regulatory Affairs in the Aesthetics Global Business Unit Leadership Team/Steering Committee,
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Champion Regulatory Device Strategy within Global Regulatory Affairs Leadership Team and with other R&D Leaders.
Skills & Qualifications
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Industry experience with 10+ years Medical Device Regulatory Affairs needed, Class III experience preferred. Pharma Regulatory a plus
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Has managed a Regulatory Affairs team
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Ability to manage other stakeholders such as R&D, Operations and Commercial
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Has worked with multiple markets and with various Notified Bodies
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Understanding of the new Medical Device Regulations (MDR)
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Knowledge of Medical Device Single Audit Program (MDSAP)
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Entrepreneurial mindset and can-do attitude
What we offer in return
As Galderma’s Global Center of Excellence for Aesthetics we have in Uppsala, a unique edge as we have on site the whole product chain from research and development to production. Here, our nearly 450 employees work on our world leading brands such as Restylane and Sculptra.
We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10-minute bike ride from Uppsala Central Station.