Director of Consulting Services - Medical Device Testing

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.

Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.

Job Description

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.

Qualifications

Key Capabilities and Qualifications:

• Experience:
  • Minimum of 10 years of experience in the medical device testing or consulting industry, or with the FDA with a strong focus on regulatory affairs, quality, and compliance.
  • Demonstrated expertise in consulting services, including client management, project leadership, and strategic growth.
  • Direct input in shaping industry policy.
  • Provide the organization early insights via internal communication methods/processes. This will inform and guide new service offering development with early information.
  • Position Eurofins as a leader in regulatory interpretation – a sage archetype in the areas of regulatory, compliance, and safety.
• Technical Knowledge:
  • In-depth understanding of regulatory pathways (e.g., 510(k), PMA, De Novo, CE Marking) and compliance requirements.
  • Familiarity with quality management systems (QMS) and