Senior Manager, Toxicology Expert

1 week ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time
About the Role

Abbott Laboratories is seeking a highly skilled Senior Manager, Toxicology to join our Global Biocompatibility Team. As a key member of our team, you will be responsible for ensuring the safety and efficacy of our medical devices through toxicological evaluation and regulatory compliance.

Key Responsibilities
  • Manage a team of toxicologists and biocompatibility specialists to ensure timely and accurate delivery of toxicology reports and regulatory submissions.
  • Develop and implement project resourcing strategies to meet business unit project demands.
  • Forecast resource needs based on business unit project demand and assign and prioritize project workload to meet scope and timeline of toxicology deliverables.
  • Evaluate, develop, and mentor staff to ensure they have the necessary skills and knowledge to perform their roles effectively.
  • Enhance and maintain SOPs, work instructions, templates, project trackers, and toxicology database to ensure compliance with regulatory requirements.
  • Collaborate and clearly communicate with internal key stakeholders, including cross-functional teams, program managers, material scientists, chemists, biologists, and toxicologists.
  • Provide guidance in designing and conducting toxicity studies to meet biological safety requirements and conduct safety assessments for new product development.
  • Author, review, approve, and provide guidance on risk assessments, regulatory documents, and interact with health authorities.
  • Review chemical characterization and biological evaluation plans and reports to ensure compliance with applicable regulations, standards, laws, etc. regarding biological safety and toxicology endpoints.
  • Oversee development and maintenance of biocompatibility deliverables to support EU Medical Device Regulations (MDR) technical files.
  • Assess biological safety and toxicology on products across all developmental phases and through the full product life cycle to ensure that released designs continue to meet biological safety requirements.
  • Perform and assist gap analysis of external standards, regulatory requirements, and guidance associated with biological safety evaluation; minimize the negative impact of such gaps on Abbott medical devices and business.
  • Maintain a working knowledge of all applicable external standards and industry requirements for the biological safety of medical devices.
Requirements
  • Advanced degree in physiology, pharmacology, toxicology, or other relevant scientific discipline with professional experience specific to medical devices.
  • A minimum of 10 years medical device toxicology experience.
  • A minimum of 5 years management experience.
  • Diplomate of the American Board of Toxicology (DABT).
  • Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993.
  • Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
  • Experience in Class III long-term implantable cardiovascular and/or neuromodulation devices.
  • Experience in applying advanced scientific principles and knowledge in biological safety and toxicology.
  • Demonstrated success with regulatory submissions and approvals.
  • Demonstrated success working in a fast-paced, highly matrixed, and geographically diverse business environment.
  • Excellent verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Computer proficiency using word processors, spreadsheets, project management, and statistical software programs.
What We Offer
  • A fast-paced work environment where your safety is our priority.
  • Training and career development, with onboarding programs for new employees and tuition assistance.
  • Financial security through competitive compensation, incentives, and retirement plans.
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs.
  • Paid time off.
  • 401(k) retirement savings with a generous company match.
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities.

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