Senior Clinical Studies Specialist

ARK Diagnostics, Inc. is seeking a Senior Clinical Affairs Specialist to lead clinical validation studies and ensure that IVD products meet scientific and regulatory standards. The ideal candidate has extensive IVD clinical experience and strong technical writing skills.

Requirements

• Establish and manage relationships with academic experts and reference laboratories
• Identify and secure well-characterized clinical specimens for FDA and IVDR design validation submissions
• Provide clinical input into design input requirements, hazard assessments, and regulatory-facing study reports

Benefits

• 401(k) and 401(k) matching
• Health, dental, and vision insurance
• Health Savings Account (HSA) and Flexible Spending Account (FSA)
• Life insurance
• Paid time off
• Employee Assistance Program (EAP)
• Tuition reimbursement
• Referral program