Technical Director - Biocompatibility
Core
Provide scientific, strategic, and commercial leadership for medical device biocompatibility testing and biological evaluation services.
Role type
Senior IC technical director (biocompatibility)
Builds
Biocompatibility testing services and biological evaluation strategies for medical device clients
Domain
Medical device industry + regulatory science
Required skills
Biocompatibility testing, biological evaluation, regulatory science, ISO 10993 series, toxicological risk assessment, FDA guidance, EU MDR, ISO 17025, GLP, strategic client engagement, business growth consultation
Preferred skills
Contract research organization experience, medical device manufacturer experience, regulatory authority experience, industry recognition, scientific publications, standards committee involvement
Technologies
ISO 10993 series, FDA biocompatibility guidance, Regulation (EU) 2017/745, ISO 17025, GLP
Responsibilities
Establish industry leadership for biocompatibility business, mentor technical staff, support strategic client relationships, expand service scope, identify profitable growth opportunities, represent company in industry activities and standards committees
Seniority
Director, strategic leadership & hands-on scientific authority