Biocompatibility Scientist

Onsite Branchburg NJ

Pay: $50-$57/hr

REQUIRED:

MS Degree in Biological Sciences or similar

4+ years of industry expereince with ISO 10993 Standard (biocompatibility)

• SME for biocompatibility evaluations
• Responsible for:
• Biological evaluation strategies
• Risk assessments
• Supporting regulatory submissions
• Materials / biomaterials
• Device safety + patient interaction

Change Control / Lifecycle Support

• Highly sought after
• Supporting on-market product changes:
• Manufacturing changes
• Material changes

Supplier changes

• ISO 10993
• Medical devices / combination products
• Biomaterials / tissue interaction
• Chemistry / biomechanics (nice to have)

Job Description:

• Non-lab biocompatibility SME role (documentation + compliance heavy)
• Focus on biological safety / risk assessment for medical devices
• Supports on-market products + change control, not just early R&D
• Highly cross-functional: works with R&D, Regulatory, Quality, Engineering

👉 This is NOT a bench scientist role — it’s:

• Scientific strategy
• Regulatory-facing documentation
• Risk assessment ownership

Day-to-Day Responsibilities

• Write and review biocompatibility risk assessments
• Lead or support biocompatibility strategy for projects
• Participate in change control activities
• Collaborate across:
• Regulatory
• Quality
• Engineering
• Monitor and coordinate external studies (CROs)

The Senior Scientist I - Biocompatibility is a SME related to the biocompatibility and nonclinical safety evaluations of medical devices, biomaterials, tissue products, and combination products as a part of Client R&D. This individual must possess an extensive knowledge of ISO-10993 Standards and prior experience working in biocompatibility. The position will be responsible for cross-functional and cross-site collaborations and recommendations of biocompatibility activities, including establishing requirements, planning, execution and approval of biocompatibility requirements in support of regulatory submissions, project teams, operations, with a large focus on manufacturing and change control (product support