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Director Biocompatibility Jobs
Company | Abbott |
Address | Santa Clara, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Hospitals and Health Care |
Expires | 2023-08-30 |
Posted at | 8 months ago |
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.
- Conduct safety assessment for new product development and provide solutions for the evaluation of safety risk for manufacturing and life cycle management challenges
- 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.
- Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility and appropriate Regulatory and Quality compliance.
- Develop and implement biocompatibility resourcing strategy to update support of business divisions needs
- Author and provide guidance on risk assessments (products/materials, impurities, leachables and extractables), author regulatory documents, and interact with Health Authorities.
- Manage relevant standards and regulations
- Responsible for meeting scope and timelines of Biocompatibility deliverables to project teams
- Mentor staff
- Manage direct staff conducting biocompatibility evaluation of medical devices across multiple divisions of Abbott
- Oversee development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files
- Serve as core team project member
- The position requires a minimum of 10 years in Biocompatibility for medical devices
- Strong oral/written communication skills
- 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.
- Experience in managing nonclinical safety studies at external facilities
- Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
- Strong computer and general software skills
- Experience working in Design Control environment
- Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
- 401(k) retirement savings with a generous company match
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- A fast-paced work environment where your safety is our priority (Manufacturing roles only)
- Paid time off
- 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
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
- Financial security through competitive compensation, incentives and retirement plans
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