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Director of Consulting Services @Eurofins

[Hiring] Director of Consulting Services @Eurofins

Apr 04, 2025 - Eurofins is hiring a remote Director of Consulting Services. đź’¸ Salary: unspecified. đź“ŤLocation: USA.

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Role Description

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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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

  • 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.
  • 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.
  • Proven experience in building and leading high-performing consulting teams, with a track record of fostering collaboration and innovation.
  • Exceptional interpersonal skills with the ability to build lasting client relationships, communicate complex regulatory requirements, and negotiate service agreements.
  • Bachelor’s degree in a related field (e.g., Engineering, Regulatory Affairs, Life Sciences). Master’s degree or equivalent is preferred.

Requirements

  • Strong analytical abilities to assess client needs, provide technical advice, and recommend effective solutions for quality and regulatory challenges.
  • Lab and manufacturing experience in GMP environment and leadership of technical teams is desirable.
  • Provide technical guidance to introduce creative solutions to a wide range of difficult problems.
  • Prepare reports or presentations and interact with client stakeholders.

Benefits

  • Exciting opportunity for a skilled professional to drive impactful client outcomes.
  • Support the success of clients in the evolving medical device industry.

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Back to Remote jobs  >   All others
Director of Consulting Services @Eurofins
All others
Salary đź’¸ unspecified
Remote Location
USA
Job Type full-time
Posted Apr 04, 2025
Apply for this position Unlock 54,865 Remote Jobs
️
đź“Ť Be aware of the location restriction for this remote position: USA
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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