• Senior Staff Scientist - Toxicology Jobs in United States Of America - 25368235

  • Abbott India Ltd
  • United States Of America, Usa
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

Job Description:

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 103,000 colleagues serve people in more than 160 countries

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

Principal Responsibilities
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 junior staff
Collaborate and clearly communicate with internal and external stakeholders (eg, 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

Qualifications
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 5 years in Biocompatibility for medical devices
Expert in US and global regulations (eg, 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

Qualifications

The position requires a Master or PhD degree in biology, biochemistry, toxicology, analytical chemistry or material science, preferably with a specialism relating to medical devices
At least 5 years of experience in Biocompatibility for medical devices
Experience in the planning and implementation of studies in the areas of residue analysis, toxicology and/or the biocompatibility of medical devices
Demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement and support the transformation of a function is required
Experience with leading multiple projects, managing priorities and resource management is required
Personal qualities such as a talent for organization, initiative, reliability, customer orientation, decision-making capacity and the ability to think and work in an interdisciplinary manner

OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL

JOB FAMILYResearch and Discovery

DIVISIONAVD Vascular

LOCATIONUnited States > Santa Clara Building B - SC Floor-1

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Bio-Technology Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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