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 115,000 colleagues serve people in more than 160 countries.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Our Medical Devices group currently has an opportunity for a Director, Biocompatibility.

What You'll Do

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 the new and existing products to meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.

Responsibilities

• Manage direct staff conducting biocompatibility evaluation of medical devices across multiple divisions of Abbott

• Develop and implement biocompatibility resourcing strategy to update support of business divisions needs

• Conduct safety assessment for new product development and provide solutions for the evaluation of safety risk for manufacturing and life cycle management challenges

• Serve as core team project member

• Author and provide guidance on risk assessments (products/materials, impurities, leachables and extractables), author regulatory documents, and interact with Health Authorities.

• Responsible for meeting scope and timelines of Biocompatibility deliverables to project teams

• Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility and appropriate Regulatory and Quality compliance.

• Oversee development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files

• Manage relevant standards and regulations

• Mentor staff

• Collaborate and clearly communicate with internal and external stakeholders (e.g., Board Certified Toxicologists and Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testing.

Key Relationships:

The position interacts directly with functional groups including R&D groups, Preclinical, Regulatory, Analytical Chemistry, and Quality groups in the Abbott various business Divisions and CROs.

Education and Experience You'll Bring

• The position requires a Master or PhD degree in biology, biochemistry, toxicology, analytical chemistry or materials science, preferably with a specialism relating to medical devices.

• The position requires a minimum of 10 years in Biocompatibility for medical devices

• 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 managing nonclinical safety studies at external facilities

• Experience working in Design Control environment

• Strong computer and general software skills

• Strong oral/written communication skills

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 (Manufacturing roles only)

· Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)

· 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

Learn more about our benefits that add real value to your life to help you live fully:  http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

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 $156,400.00 – $312,800.00. In specific locations, the pay range may vary from the range posted.