Senior Biocompatibility Scientist, ISO 10993 Expert

AbbVie Inc.

Branchburg Township (NJ)

On-site

USD 97,000 - 184,000

Full time

12 days ago

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Job summary

AbbVie Inc. is seeking a Sr Scientist I - Biocompatibility to support biocompatibility evaluation requests for marketed AbbVie medical devices. You will lead change control activities, organize assessments, ensure regulatory documentation, and deliver biocompatibility training.

The role requires ISO 10993 expertise, regulatory knowledge, and strong technical writing skills. You will collaborate globally with manufacturing sites and lifecycle teams to ensure compliance and successful project

Qualifications

  • Bachelor’s degree in Life Science or related field with 10+ years in scientific role in medical device/pharma.

Responsibilities

  • Lead regulatory change control for ISO 10993 impact and global market products.
  • Develop and deliver biocompatibility training for internal stakeholders.
  • Prepare documentation for regulatory submissions and responses.
  • Collaborate with cross-functional teams across manufacturing sites and product lifecycle functions.
  • Support projects in development for biocompatibility activities.

Skills

Technical writing
ISO 10993
Regulatory compliance
Training delivery
Cross-functional collaboration
Change control

Education

Bachelor’s Degree in Life Science or related field
Master’s degree in Life Science or related field

Tools

EDMS
Microsoft Office
Change management
Documentation control

Job description

AbbVie Inc. is seeking a Sr Scientist I - Biocompatibility to support biocompatibility evaluation requests for marketed AbbVie medical devices. You will lead change control activities, organize assessments, ensure regulatory documentation, and deliver biocompatibility training.

The role requires ISO 10993 expertise, regulatory knowledge, and strong technical writing skills. You will collaborate globally with manufacturing sites and lifecycle teams to ensure compliance and successful project

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