Job Description

We are seeking an experienced consultant with a strong background in combination products quality systems and clinical operations to support a focused remediation and compliance initiative. This project will involve a comprehensive review of existing Clinical Operations procedures and supporting documentation to assess alignment with combination product development requirements and applicable global regulatory expectations.

Responsibilities

• Review and assess current Clinical Operations SOPs and associated quality documents, including templates, forms, and work instructions
• Evaluate whether the existing SOP framework adequately supports combination product development and clinical execution activities
• Conduct gap assessments to identify missing, incomplete, overlapping, outdated, or inconsistent procedures and documentation
• Assess alignment with:
• 21 CFR Part 4 requirements
• Combination product quality system expectations
• Clinical Operations regulatory expectations
• Applicable regional and international regulatory considerations
• Review and provide recommendations regarding regional requirements across:
• United States
• European Union
• United Kingdom
• Australia
• Japan
• South Korea
• Canada
• Switzerland
• Develop remediation recommendations and procedural improvement strategies to support compliance, inspection readiness, and operational efficiency
• Collaborate cross-functionally with Quality, Regulatory Affairs, Clinical Operations, and other stakeholders to support project objectives
• Provide clear documentation of findings, risk areas, and recommended corrective actions

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related discipline
• 7+ years of experience in the medical device, pharmaceutical, biotechnology, or combination products industry
• Demonstrated experience with combination product quality systems and Clinical Operations processes
• Strong working knowledge of 21 CFR Part 4 and applicable global regulations related to combination products
• Hands-on experience performing SOP reviews, gap assessments, remediation activities, and procedural harmonization projects
• Experience supporting global or multi-regional regulatory and quality compliance initiatives
• Familiarity with regional regulatory considerations across the US, EU, UK, Australia, Japan, South Korea, Canada, and Switzerland preferred
• Strong understanding of design controls, risk management, and clinical development processes for combination products
• Excellent technical writing, communication, and stakeholder collaboration skills
• Ability to work independently and provide strategic recommendations in a consulting environment
• Prior experience supporting combination product clinical development programs
• Experience preparing organizations for inspections or regulatory audits
• Background in quality system remediation or quality transformation initiatives
• Experience working within highly regulated environments supporting both device and pharmaceutical requirements

Location

• Remote

Employment Type

• Consulting

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp-to-permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled