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.

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 standards such as ISO 13485 and FDA 21 CFR Part 820.
  • Submission and Regulatory strategies supporting successful product submission.
  • Keen understanding of the Product lifecycle
  • Provide technical guidance to introduce creative solutions to a wide range of difficult problem.
  • Prepare reports or presentations and interact with client stakeholders.
  • Lab and manufacturing experience in GMP environment and leadership of technical teams is desirable.
• Leadership and People Management:
  • Proven experience in building and leading high-performing consulting teams, with a track record of fostering collaboration and innovation.
• Analytical and Problem-Solving Skills:
  • Strong analytical abilities to assess client needs, provide technical advice, and recommend effective solutions for quality and regulatory challenges.
• Communication and Relationship Building:
  • Exceptional interpersonal skills with the ability to build lasting client relationships, communicate complex regulatory requirements, and negotiate service agreements.
• Education:
  • Bachelor’s degree in a related field (e.g., Engineering, Regulatory Affairs, Life Sciences). Master’s degree or equivalent is preferred.

This role provides an exciting opportunity for a skilled professional to drive impactful client outcomes, shape the future of consulting services, and support the success of clients in the evolving medical device industry.

Disclaimer:

This position description is written as a guideline to inform employees of what is generally expected of them at each job level.  The description is not intended to be all encompassing or limiting in any manner; rather, it is hoped it will add understanding and better reflect the work performed at all levels of employment.  Duties and responsibilities other than those listed may be included as needed within the work group or the company as a whole.

The above information may not be used or duplicated by others without written consent.

We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development.

We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

Sustainability matters to us!  We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!

Find out more in our career page: https://careers.eurofins.com/

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.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralized and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2023, Eurofins generated total revenues of EUR 6.515 billion ($7.018 billion), and has been among the best performing stocks in Europe over the past 20 years.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.