Research Fellow, Medical Device Toxicologist

Responsibilities

• Manage team responsible for medical device biocompatibility support
• Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices
• Ensures that development and execution of nonclinical strategies are aligned with product development and life cycle management activities, and with key regulatory expectations and milestones
• Ensures that essential nonclinical data are obtained, and effectively presented for successful clinical development, regulatory and quality compliance, market launch, and maintenance of business
• Coaches and mentors junior staff
• Deep understanding of medical device relevant standards, staying abreast of changes to applicable industry practice and guidance documents
• Implement new and revised standards into product development projects and/or assess impact on existing products as appropriate
• Authors and reviews department’s technical documents as needed
• Manage interactions with other functions (e.g., Product Development, Clinical Development, Analytical Chemistry, Regulatory, Quality, Compliance)
• Liaise with company international offices on nonclinical safety matters for country-specific submissions/registrations and maintenance of business activities

Requirements

• Ph.D. in Toxicology or related discipline
• 12+ years of relevant Medical Device industry experience
• DABT preferred
• Ophthalmic medical device experience a plus