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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.

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 .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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.

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 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 (e.g., ISO 10993 Series, ISO 14971, ISO 21726, Regulation (EU) 2017/745, 2023 FDA Guidance on Use of ISO 10993-1, etc.)

• Author/Co-author industry influencing publications in peer reviewed journals

Key Relationships

The position interacts directly with functional groups including R&D, Operations, Preclinical, Regulatory, and Quality groups in Abbott’s various business Divisions and CROs.

Required Qualifications

• 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

Preferred Qualifications

• Has regularly appeared as first or senior author on peer-reviewed publications

• Regularly presents at scientific conferences

• Experience with medical device design, biomaterials, E&L analysis for materials, container-closure systems, manufacturing processes, product life cycle, etc. in the medical device industry per applicable standards

• Experience in GLP toxicity studies in both small and large animal models

• Experience in working in a broader shared service/cross-division business unit model

• Experience in working with technical standard organizations (ISO, AAMI, ASTM, etc.)

WHAT WE OFFER :

At Abbott, you can have a good job that can grow into a great career. 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

Apply Now (https://www.jobs.abbott/us/en)

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $125,300.00 – $250,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com