Not specified (assumed hybrid based on industry norms).
Biocompatibility program management
Iso-10993 and iso-14971 regulations
Cytotoxicity and sensitization testing
Acumed LLC is seeking a Biocompatibility Program Manager to oversee its biocompatibility initiatives, ensuring compliance with industry standards for medical devices. The role involves cross-functional collaboration, management of biocompatibility documentation, and communication of program updates to executives
Job Summary
The Biocompatibility Program Manager is responsible for establishing and directing all aspects of the biocompatibility program to ensure safe use of products in patients.
This role requires working cross-functionally with business units to apply biocompatibility principles to new product development and training staff on compliance procedures.
Candidates must manage external vendors, utilize project management tools, and present program updates to executive teams while adhering to FDA and EU-MDR regulations.
Matching Summary
Match Score: 85
Acumed LLC is seeking a Biocompatibility Program Manager to oversee its biocompatibility initiatives, ensuring compliance with industry standards for medical devices. The role involves cross-functional collaboration, management of biocompatibility documentation, and communication of program updates to executives.
Skills & Requirements
Must-have
Biocompatibility program management
ISO-10993 and ISO-14971 regulations
Cytotoxicity and sensitization testing
Statistical analysis of biological data
External vendor and consultant management
Design control process implementation
Nice-to-have
Advanced education in toxicology or microbiology
Experience with SAP, Windchill, and CAD software
Strong technical writing and presentation skills
Matrixed organization experience
Executive team reporting capabilities
Key Requirements
Bachelor's degree in biological sciences, physical sciences, or engineering
Minimum 5 years of experience with surgically invasive and implantable biocompatibility principles
Proficiency in ISO-10993, ISO-14971, FDA, and EU-MDR regulations