Senior Biocompatibility Scientist (Hybrid) for Submissions

Sitka Inc.; Flagstaff (AZ); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Gore is seeking a Senior Biocompatibility Scientist to ensure the biological safety of Gore medical devices by interfacing with product development, regulatory, and commercial teams to facilitate FDA and global approvals.

The role can be located at Gore’s facility in Flagstaff, AZ or Phoenix, AZ with a hybrid work arrangement. The candidate will contribute to biocompatibility strategies and regulatory readiness across multiple projects.

Qualifications

• Doctoral degree in biological sciences or related field with a minimum of 3 years in medical devices, or Master’s with at least 5 years in medical devices.
• Active participation in AAMI and/or ISO standard working groups or committees for medical device biocompatibility.
• Strong understanding of ISO 10993 and hands-on regulatory submission experience.
• Excellent written and verbal communication skills and ability to collaborate with regulatory, technical and business stakeholders.

Responsibilities

• Develop biocompatibility evaluation plans per ISO 10993-1 for devices in development or changes to commercial devices.
• Provide biological safety assessments for product/process changes.
• Manage multiple biocompatibility projects with timelines, budgets, risks, and stakeholders.
• Coordinate sample testing with contract labs and oversee test reports and acceptance criteria.
• Assist in preparing regulatory submissions and respond to agency questions on biocompatibility.

Skills

Biocompatibility expertise

Regulatory collaboration

Project management

Scientific writing

Cross-functional teamwork

Education

PhD in biological sciences

Master's in biological sciences

Job description

Gore is seeking a Senior Biocompatibility Scientist to ensure the biological safety of Gore medical devices by interfacing with product development, regulatory, and commercial teams to facilitate FDA and global approvals.

The role can be located at Gore’s facility in Flagstaff, AZ or Phoenix, AZ with a hybrid work arrangement. The candidate will contribute to biocompatibility strategies and regulatory readiness across multiple projects.