Biocompatibility Scientist – Regulatory Submissions (Hybrid)

W. L. Gore & Associates, Inc.; Phoenix (AZ); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work arrangement

Travel up to 10%

Job summary

W. L. Gore & Associates, Inc. is seeking a Senior Biocompatibility Scientist to ensure the biological safety of Gore medical devices.

The role interfaces with development, regulatory, and commercial teams to facilitate regulatory approval worldwide. The position is located in Flagstaff or Phoenix, Arizona, with potential for a hybrid work arrangement. The candidate will drive biocompatibility strategies, participate in standards committees, and support pre-submission activities for global health

Qualifications

• PhD in biological sciences or related field with 3+ years in medical devices
• MS in biological sciences or related field with 5+ years in medical devices
• Active participation in AAMI and/or ISO standard groups or committees pertaining to biocompatibility
• Strong understanding of ISO 10993 standards and global regulatory submissions
• Excellent written and oral communication with stakeholders across disciplines
• Ability to work across in-person and virtual teams
• Occasional travel up to 10% of time

Responsibilities

• Develop biocompatibility evaluation plans per ISO 10993-1
• Provide biological safety assessments for changes
• Manage multiple biocompatibility projects with timelines and budgets
• Coordinate with contract labs and manage test samples
• Review lab reports and address findings for regulatory submissions
• Prepare documentation for health authority submissions and pre-submissions
• Represent Gore on biocompatibility standards committees

Skills

Biocompatibility evaluation

Cross-functional collaboration

Regulatory submissions

Project management

Communication skills

Teamwork

Education

PhD in biological sciences or related field

MS in biological sciences or related field

Job description

W. L. Gore & Associates, Inc. is seeking a Senior Biocompatibility Scientist to ensure the biological safety of Gore medical devices.

The role interfaces with development, regulatory, and commercial teams to facilitate regulatory approval worldwide. The position is located in Flagstaff or Phoenix, Arizona, with potential for a hybrid work arrangement. The candidate will drive biocompatibility strategies, participate in standards committees, and support pre-submission activities for global health