Staff Scientist II

Responsibilities

• Contribute as local SME to the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation strategies and programs according to relevant regulatory requirements; including review of literature and assessment of compliance.
• Collaborate with CPDT SMEs, BD project teams, business unit regulatory affairs staff, R&D staff and outside suppliers as required to help define product testing requirements and coordinate with the project team to provide CPDT deliverables.
• Serve as Sponsor Representative for biocompatibility and chemistry studies and contribute to design, execution, and interpretation of preclinical, biocompatibility, chemistry and toxicological evaluation programs for medical devices within client.
• Support EU MDR remediation efforts, create biocompatibility evaluation reports, and conduct testing as needed to ensure compliance under the EU MDR.
• Maintain historical databases and perform searches of historical data, as needed.

Requirements

• Bachelor’s degree in toxicology or a closely related field and a minimum of 8 years of pre-clinical medical device development experience OR Master’s degree in toxicology or a closely related field and a minimum of 5 years pre-clinical medical device development experience OR PhD Degree in toxicology or a closely related field and a minimum of 2 years pre-clinical medical device development experience years relevant experience or a combination of equivalent education and relevant experience.
• Board certification in toxicology preferred (e.g., DABT, ERT).
• Experience in a GLP preclinical environment preferred.

Qualifications

• Working knowledge of computers (Word, Excel, Access, PowerPoint, SharePoint).
• A broad background in biology/biocompatibility, toxicology and analytical chemistry including familiarity with recent methodologies and evaluation techniques (i.e., ISO 10993 and related guidance).
• Experience in a United States or EU medical device setting preferred.

Skills

• Ability to communicate and work effectively with national and international, internal, and external teams.
• Must be able to multitask and operate effectively within a diverse work environment.
• Must be team oriented and have strong interpersonal skills and customer focus while functioning independently as an SME.
• Must have excellent scientific written and verbal communication skills.