Job Description
Roles & Responsibilities
- Act as the local SME in the design, execution, and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation strategies and programs, ensuring regulatory compliance.
- Collaborate with CPDT SMEs, project teams, regulatory affairs, R&D, and external suppliers to define product testing requirements and provide CPDT deliverables.
- Serve as the Sponsor Representative for biocompatibility and chemistry studies, supporting medical device evaluation programs.
- Contribute to EU MDR remediation efforts by creating biocompatibility evaluation reports and conducting required testing to ensure compliance.
- Maintain historical databases and perform searches for relevant data when necessary.
Experience Required
- Bachelor’s, Master’s, or PhD degree in toxicology or a related field, with 2-8 years of pre-clinical medical device development experience depending on the level of education.
- Experience in a GLP preclinical environment is preferred.
- Experience in a U.S. or EU medical device setting is advantageous.
- Board certification in toxicology (e.g., DABT, ERT) is preferred.
Skills & Certifications
- Broad knowledge of biology, biocompatibility, toxicology, and analytical chemistry, including familiarity with ISO 10993 and related regulatory guidance.
- Strong interpersonal and communication skills, both verbal and written, with the ability to work effectively with internal and external teams, including international stakeholders.
- Proficiency in Microsoft Office (Word, Excel, Access, PowerPoint, SharePoint).
- Strong multitasking and time-management abilities in a diverse work environment.
Eligibilities & qualifications
- Bachelor’s, Master’s, or PhD degree in toxicology or a related field.
- Minimum of 2–8 years of relevant pre-clinical medical device development experience, depending on educational qualifications.
- Ability to function independently as an SME while being team-oriented.
- Strong customer focus with the ability to work in a dynamic, cross-functional environment.
Job Tags
Full time, Work at office, Local area,