Principal Scientist, Biocompatibility
GE HealthcareSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical DevicesIndustries
Requirements
- Master or PhD degree in biology, biochemistry, toxicology, analytical chemistry or materials science, preferably with a specialism relating to medical devices
- 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 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
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
Skills
Biocompatibility
ISO 10993
EU MDR
Medical Devices
Risk Assessment
Safety Assessment
Regulatory Compliance
Leachables
Extractables
Technical Files
Abbott
Healthcare solutions in diagnostics and devices
About Abbott
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.
Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees