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Senior Scientist, I: Biocompatibility

Job Overview

In addition, this individual will be responsible for creation (with minimal supervision) and delivery of biocompatibility training and continuing education for internal stakeholders. Additional support for projects in development for biocompatibility activities is a responsibility of this role.

Key points

  1. The Sr Scientist I - Biocompatibility is an SME who will support biocompatibility evaluation requests related to marketed products for AbbVie global medical devices.

  2. This includes interfacing with AbbVie manufacturing site change requestors to lead change control activities, organize timely assessments with the biocompatibility team…

  3. This role requires expertise in ISO 10993, medical device regulations, and formal change control processes/platforms, with a strong focus on technical writing, controlled documentation.

  4. Must possess knowledge of ISO-10993 Standards and quality management systems, with prior experience working in in marketed product support for medical devices.

  5. Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success supporting marketed products is preferred…

  6. Significant experience and knowledge of medical devices and combination product regulations.

  7. Strong technical writing and verbal communication skills; ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).

  8. Strong training and education experience.

Skills

Stakeholder ManagementCommunicationProblem Solving

Experience: Senior-level · 8+ years · Job type: Full-time