Full-Time Director of Consulting Services - Medical Device Testing

Director of Consulting Services will lead and develop consulting business, building strategic vision and team to support medical device clients.

Key Responsibilities:

• Develop and implement a business vision for leading consulting services in medical device testing.
• Define and execute strategies for growth in consulting services and expanding offered services.
• Build strong client relationships as a strategic partner in product innovation and regulatory compliance.
• Ensure client satisfaction by delivering high-quality consulting services that exceed expectations.
• Lead assessments and develop strategies for supporting clients with compliance, quality assurance, and process improvement.
• Design and implement consulting services covering critical areas like pre-clinical/clinical support, regulatory/quality compliance (e.g., 510(k), PMA), safety/engineering consulting, market access/reimbursement, technical consulting (toxicological risk assessments), life cycle management and outsourced regulatory affairs.
• 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.
• Stay informed about industry trends, regulatory changes, and emerging technologies.
• Represent the organization in industry forums, conferences, and client meetings.

Key Capabilities and Qualifications:

• Minimum 10 years' experience in medical device testing/consulting industry or with FDA (regulatory affairs, quality, compliance)
• Expertise in consulting services (client management, project leadership, strategic growth)
• Direct input in shaping industry policy
• Provide early insights for new service offerings
• Position Eurofins as a leader in regulatory interpretation

Technical Knowledge:

• In-depth understanding of regulatory pathways (510(k), PMA, De Novo, CE Marking) and compliance requirements.
• Familiarity with quality management systems (QMS) and standards like ISO 13485 and FDA 21 CFR Part 820
• Submission and regulatory strategies supporting successful product submission.
• Understanding of the product lifecycle
• Technical guidance for creative solutions to complex problems
• Report preparation and client stakeholder interaction
• Laboratory and manufacturing experience in GMP environment and leadership of technical teams (desirable)

Leadership and People Management: Proven experience building and leading high-performing teams.

Analytical and Problem-Solving Skills: Strong analytical skills for assessing client needs and recommending solutions for quality and regulatory challenges.

Communication and Relationship Building: Exceptional interpersonal skills, building lasting relationships, communication of complex regulations, and negotiating service agreements.

Education: Bachelor's degree in related field (e.g., Engineering, Regulatory Affairs, Life Sciences). Master's degree preferred.

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