Architect, Medical Device Consulting (Part Time)

Eurofins Medical Device Consulting is seeking a highly experienced entrepreneurial Architect Medical Device Consulting to support the development and launch of our new consulting division. Reporting directly to the Senior Director of Consulting Services this part-time role will help shape service offerings align consulting services with existing testing capabilities and accelerate go-to-market readiness.

This is a high-impact opportunity for a MedTech-focused professional who thrives in start-up environments enjoys building frameworks from the ground up and is motivated by strategic influence and cross-functional collaboration.

Key Responsibilities:

Service & Capability Development

• Evaluate Eurofins current medical device testing capabilities to identify opportunities for bundling with consulting services.
• Map internal capabilities to external market needs to help define and prioritize initial service offerings.
• Assist in designing scalable consulting solutions in areas such as regulatory submissions biologic safety quality remediation and life cycle management.
• Contribute to the creation of internal frameworks templates and tools for consistent service delivery.

Strategic Marketing & Sales Enablement

• Partner with the Marketing team to develop educational materials service brochures and thought leadership content that accurately position our consulting value.
• Train the Business Development team on service offerings value propositions and how to qualify and sell consulting services effectively.
• Support strategic account discussions and select client engagements to ensure credibility and alignment of services.

Organizational Build-Out

• Provide input on the hiring plan and assist in identifying and vetting subject matter experts in key focus areas (e.g. regulatory affairs biologics quality systems).
• Help establish scalable onboarding training and knowledge-sharing practices for the consultant network.
• Participate in shaping internal governance for quality delivery consistency and risk mitigation.

Market and Competitive Intelligence

• Conduct focused market and competitor analysis to identify high-demand areas and gaps Eurofins can uniquely fill.
• Share regulatory intelligence and insights to guide service evolution and new offering development.

Qualifications :

• Minimum 10 years of experience in MedTech focused on regulatory affairs for medical devices including deep familiarity with FDA and EU MDR pathways (510(k) De Novo PMA CE Marking).
• Prior consulting experience and a demonstrated ability to design and deliver service offerings.
• Strong understanding of biocompatibility and product safety testing and how these align with regulatory strategies.
• Entrepreneurial mindset with the ability to work independently in a fast-moving start-up environment.
• Excellent communication and collaboration skills with a proven ability to influence cross-functional teams and external stakeholders.
• Experience supporting marketing sales enablement or client-facing solution development preferred.

Additional Information :

Eurofins USA Medical Devices is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Part-time