Remote Biocompatibility & Regulatory Expert

Nelson Laboratories, LLC; Salt Lake City (UT); On-site; USD 100,000 - 130,000; Full time

Job summary

Nelson Laboratories, LLC is seeking an Expert Biocompatibility Consultant to lead biocompatibility assessments for medical device products in regulated environments. The role involves developing assessments, providing guidance, and authoring risk documents.

Ideal candidates will have significant experience in a medical device context, strong technical writing skills, and a solid understanding of relevant FDA regulations. The position offers flexibility with remote work and some travel requirements.

Qualifications

• 7+ years of experience in biocompatibility assessments in medical devices.
• Expertise in authoring assessments and regulatory documents.
• Strong knowledge of FDA regulations and ISO10993.

Responsibilities

• Lead development and authorship of crucial biocompatibility assessments.
• Apply ISO10993 principles to regulatory submissions.
• Communicate scientific rationale to stakeholders.

Skills

Biocompatibility assessment

Technical writing

Verbal communication

Regulatory knowledge

Education

Bachelor’s degree in relevant field

MS/PhD in relevant field

Job description

Nelson Laboratories, LLC is seeking an Expert Biocompatibility Consultant to lead biocompatibility assessments for medical device products in regulated environments. The role involves developing assessments, providing guidance, and authoring risk documents.

Ideal candidates will have significant experience in a medical device context, strong technical writing skills, and a solid understanding of relevant FDA regulations. The position offers flexibility with remote work and some travel requirements.