Senior Manager, Toxicology

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.

You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Our location in St. Paul, MN, currently has an opportunity for a Senior Manager, Toxicology.

THIS POSITION IS AN ONSITE DAILY REQUIRED ROLE.

MAIN PURPOSE OF ROLE

Responsible for Biocompatibility support to the research & development of new medical device products as well as the maintenance of business activities by ensuring that adequate documentation exists for all new and existing products to meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.

This is a manager and senior-level technical contributor responsible for serving as a leader in biocompatibility, focusing on the toxicological evaluation of products and technologies required for product approvals and ensuring patient safety in accordance with applicable global regulatory guidelines.

This position works out of our St. Paul, MN location and will serve the Global Biocompatibility Team, with responsibilities for medical device biological evaluation spanning Cardiac Rhythm Management, Electrophysiology, Heart Failure, Neuromodulation, and Structural Heart business units.

MAIN RESPONSIBILITIES

• Manage direct staff conducting toxicological evaluation of medical devices
• Develop and implement project resourcing strategy
• Forecast resource needs based on business unit project demand
• Assign and prioritize project workload to meet scope and timeline of toxicology deliverables
• Evaluate, develop, and mentor staff
• Enhance and maintain SOPs, work instructions, templates, project trackers, and toxicology database
• Collaborate and clearly communicate with internal key stakeholders (e.g. cross functional team of program managers, material scientists, chemists, biologists, and toxicologists)
• Provide guidance in designing and conducting toxicity studies to meet biological safety requirements
• Conduct safety assessments for new product development and provide solutions for the evaluation of safety risk for manufacturing and life cycle management challenges
• Author, review, approve, and provide guidance on risk assessments (products/materials, impurities, leachables and extractables)
• Author 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 wit