Director of Consulting Services - Medical Device Testing

Position Overview: 

The Director of Consulting Services will lead and develop our consulting business, building a strategic vision and team to support our clients in the medical device industry across their product innovation, regulatory compliance, and quality assurance processes. This role will focus on establishing core services that cater to the entire product lifecycle, from pre-clinical and clinical support to regulatory affairs and market access.

Key Responsibilities:

1. Strategic Leadership and Vision
   • Develop and implement a business vision that positions the organization as a leader in consulting services for the medical device testing industry.
   • Define and execute strategies to drive growth in consulting services and expand the range of services offered to clients.
2. Client and Project Management Oversight
   • Build strong team and relationships with clients, acting as a strategic partner in their product innovation and regulatory compliance journeys.
   • Ensure client satisfaction by overseeing the delivery of high-quality consulting services that meet or exceed client expectations.
   • Lead assessments and develop strategies to support clients with compliance, quality assurance, and process improvement.
3. Core Service Program Development
   • Design and implement consulting services covering critical areas, including:
     • Pre-Clinical and Clinical Support: Guidance on study design, data analysis, and regulatory submission strategies.
     • Regulatory and Quality Compliance: Support for compliance with regulatory requirements, including US FDA 510(k), De Novo, PMA, and Breakthrough Device submissions.
     • Safety and Engineering Consulting: Evaluate product safety, engineering processes, and risk assessments.
     • Market Access and Reimbursement: Develop strategies for product reimbursement and market access.
     • Technical Consulting: Provide expertise on toxicological risk assessments, gap analysis, and adverse test result management.
     • Life Cycle Management and Outsourced Regulatory Affairs: Offer ongoing support in regulatory submissions, remediation, and life cycle management.
4. Team Leadership and Development
   • Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs, and quality management.
   • Foster a culture of continuous learning and innovation, equipping the team with the skills and knowledge to meet evolving industry standards.
5. Industry Engagement and Market Awareness
   • Stay informed about industry trends, regulatory changes, and emerging technologies in medical device testing.
   • Represent the organization in industry forums, conferences, and client meetings, building the brand and establishing thought leadership.