Director Regulatory Affairs Medical Devices(all genders)
We are looking for an experienced Director Regulatory Affairs Medical Devices (all genders) who will be responsible for the regulatory strategy of our medical device business and leading the Regulatory Affairs team within Bioelectronics.
As the Director Regulatory Affairs, you will have a key role in building global regulatory plans that strengthen our market position and meet our business objectives.
You will develop the regulatory paths for novel implantable neurostimulation devices and innovative digital healthcare solutions.
In this role, you will manage and oversee our teams related to the design process, the communication with global regulators, as well as various regulatory submissions of highly innovative class III medical devices (CE-mark, FDA 510K or PMA).
In close interaction with our Healthcare regulatory organization, you will ensure regulatory compliance, prepare country registrations and provide guidance to the leadership team.
In close alignment with the VP & Head of Bioelectronics you will be accountable for the success of our Bioelectronics business at the current frontier of medicine at our headquarters in Darmstadt.
Who you are : PhD or Master in a life science, engineering or related disciplineMinimum of 10 years experience working in Regulatory Affairs within medical device environments, with min.
5 years track-record successfully managing Regulatory Affairs teams bringing products to market Strong track record in leading teams in global regulatory matters of implants (class 3 medical devices) and Software as a Medical Device (SaMD) Proven expertise in compiling FDA and other regulatory submissions (Pre-IDE, IDE, 510(K), PMA, Design Dossier) Good understanding of the clinical development process, trial design aspects, and relevant clinical regulatory frameworks such as ICH, GCP, MDR, MPDGStrong team player;
able to work within a highly multidisciplinary environment Effective communication with team members and stakeholders with diverse backgroundsFluency in English required, German language knowledge desirable.
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