Regulatory Affairs Manager/Leader
From our offices in Berlin, Adaptive Life Science is working with an innovative Digital Health start up to source Regulatory Affairs talent with experience of 'Software as a Medical Device'. The new MDR's are expected to catch up on the gap that has been the regulation of medical software and we have opportunities at a number of levels for motivated individuals looking for their next challenge.
This urgent requirement in Berlin is for a RA Specialist/Manager to join the leading MedTech start up. They are passionate about medical advancement and technology, innovative and award winning. The team are extremely international and offers great flexibility and benefits, including work from home options.
Regulatory Experience/Skills Required:
+ Familiar with Software as Medical Device (SaMD) and related regulations and guidance governing product development.
+ Experience of Software / Electronic / Programmable (60601, 62304) medical devices.
+ Experience with Quality Management Systems compliant with ISO 13485, also experienced with 820 CRF 21.
+ Experienced with EU MDD/MDR Submissions, FDA 510k Submissions and exposure to emerging markets a bonus.
+ Understanding of Agile development and the Software Development Life Cycle.
+ Risk Management experience working to ISO 14971.
+ Strong German and English communication skills.
+ You will be a technologist coupled with the desire to produce Medical Devices to enhance the lives of the world's population.
If you tick the above boxes for experience, or have relevant practical experience then do reach out to us and begin your journey to your next job.
** Fully remote working and onboarding for the successful candidate during travel restrictions**
Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+44 208 638 5376