Head of Toxicology Hamburg Medical Devices
Within the area of BioPharma, I am looking for a Head of Consulting who will assume the overall responsibility for, and lead the rapidly growing Medical device consulting team.
I am looking to speak to Consultants who have completed studies as a Toxicologist and are an expert within this area.
Within this position you will assume the responsibility for the development of toxicological, analytical methods, the approval of test strategies and processing of toxicological issues, (especially in vitro tests such as alternative toxicity and genotoxicity)
You will offer advice and support to clients on the definition of optimal test strategies and interpreting difficult test results and also advise clients on positive results in the area of cytotoxicity and genotoxicity
Along with your team, you will create expert statements, biocompatibility assessments, GAP analysis according to the state of the Technology and alignment to international standards keeping within the Global Regulatory Strategy.
To be successful within this position you will have many years of professional experience in scientific research or testing laboratories along with medical knowledge of the use of medical devices and Scientific expertise in the development and validation of in vitro / in vivo tests.
Good knowledge of GLP, GMP, ISO 17025, ISO 10993 along with expert knowledge of medical device law and the EU guidelines for medical devices, MDD, MDR
Knowledge of the global approval guidelines (FDA, CFDA, MHLW etc.) and the global test guidelines: OECD, ISO, OPPTS, ASTM would be an advantage.
For a confidential chat, please get in touch.
Michelle Jarvis
michelle.jarvis@sampsoneurope.com
+44 1626 362 144