Reg Affairs, Evidence, Market Access Consultant, IVD

Orbis Clinical is seeking a remote-based Regulatory Affairs, Evidence & Market Access Consultant, IVD for 12 months.

Overview

An early-stage diagnostics company is seeking a senior Regulatory Affairs, Evidence & Market Access Consultant to support development of a novel blood-based in vitro diagnostic.

This fully remote engagement will begin on a fractional basis and may expand substantially as the program advances. The consultant will work closely with executive, scientific, and clinical stakeholders to define the regulatory path, determine what evidence is needed, and build a clear strategy for validation and eventual reimbursement.

Job Description

• Assess the current regulatory and evidence position and identify key gaps
• Evaluate intended-use and claims options and recommend a path forward
• Define the evidence needed to support regulatory and future coverage objectives
• Shape analytical validation strategy, including performance requirements and acceptance criteria
• Provide regulatory and evidence-development input into prospective diagnostic study design
• Identify potential bias or evidence risks before study execution
• Advise on appropriate U.S. regulatory pathways for the IVD
• Incorporate coding, coverage, and reimbursement considerations into the broader development strategy
• Develop clear regulatory and evidence-development roadmaps
• Prepare high-quality technical and regulatory documentation for external review
• Collaborate closely with executive, scientific, and clinical stakeholders throughout strategy development

Requirements & Experience

• Strong regulatory affairs experience within IVDs or diagnostics
• Demonstrated experience with intended use, claims strategy, and evidence requirements
• Experience shaping analytical validation strategy and acceptance criteria for diagnostic products
• Strong understanding of clinical validation and diagnostic study design
• Working knowledge of market access, reimbursement, coding, and coverage considerations
• Strong knowledge of U.S. FDA pathways for diagnostic products
• Exceptional scientific, technical, and regulatory writing skills
• Early-stage or startup experience strongly preferred
• Highly collaborative working style with experience partnering closely with executive and scientific leadership
• Comfortable starting fractionally and increasing commitment as program needs grow
• Quality/QMS experience within diagnostics is a plus, but not required

Degree/Education Requirements

• Bachelor’s degree in a scientific, engineering, regulatory, clinical, or related discipline required. Advanced degree preferred but not required based on relevant industry experience.

Years of Experience

• Approximately 7+ years of relevant regulatory, clinical/evidence, or diagnostic development experience preferred, with meaningful hands-on experience supporting IVD or diagnostic products.

Compensation Details

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $135.00-$180.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.