Director, Regulatory and Quality

Director, Regulatory and Quality

About MDC Associates

MDC Associates helps innovators bring in vitro diagnostics (IVDs) and medical devices to market. For more than 35 years, we have combined regulatory and quality expertise with clinical research, clinical operations, and data management services to help clients move from development through market authorization.

Our experience spans microbiology, clinical chemistry and infectious disease. We bring senior expertise, direct access, and personal accountability to our client relationships.

Role Overview

We are seeking a hands-on Director of Regulatory Affairs & Quality to lead MDC’s regulatory and quality consulting services and oversee our internal quality management system.

This role combines team leadership, direct client consulting, and business development support. The Director will develop employees and consultants, guide regulatory strategy, oversee the quality and financial performance of client engagements, and help grow MDC’s services. The Director will also play a key role in MDC’s Pathway Program, helping clients define a clear route to market by aligning regulatory strategy, quality requirements, and clinical evidence needs into a coordinated plan.

Key Responsibilities

Department and Team Leadership

• Lead the day-to-day operations of the Regulatory Affairs and Quality functions, including employees and external consultants.
• Recruit, mentor, and develop team members; align expertise and capacity with client needs and company growth.
• Oversee project assignments, budgets, timelines, and deliverable quality, and serve as an escalation point for complex client issues.
• Establish department goals and performance measures and contribute to MDC’s long-term planning.

Client Regulatory and Quality Consulting

• Develop practical regulatory strategies for IVD and medical-device clients.
• Lead or oversee FDA submissions and interactions, including Pre-Submissions and 510(k)s, and support De Novo requests, PMAs, and other pathways as applicable.
• Guide analytical and clinical study planning to ensure evidence supports regulatory objectives, working closely with MDC’s clinical and data teams.
• Lead or oversee client quality-system development, implementation, gap assessments, remediation, and internal and supplier audits.
• Coordinate with specialist consultants on international submissions and technical requirements as needed.
• Build trusted client relationships through clear advice, responsive communication, and accountable delivery.

Internal Quality Oversight

• Oversee the maintenance and continuous improvement of MDC’s quality management system in accordance with applicable ISO 9001 requirements and client contractual requirements.
• Lead audit readiness, represent MDC during external audits, and oversee responses and corrective actions.
• Serve as Management Representative when designated.

Business Development and Collaboration

• Partner with Business Development to assess client needs, participate in prospective-client discussions, and develop proposals, scopes of work, resource estimates, and budgets.
• Collaborate with clinical operations and data management to deliver coordinated services.
• Identify opportunities to expand client relationships and improve the efficiency and quality of MDC’s services.

Required Qualifications

• Bachelor’s degree in a relevant scientific, engineering, or related discipline.
• At least 10 years of relevant regulatory affairs experience, including substantial hands-on experience with IVD products.
• Demonstrated experience leading FDA IVD submissions and direct FDA interactions, particularly 510(k)s and Pre-Submissions.
• Experience leading teams or managing consultants, including mentoring, resource planning, and oversight of deliverables.
• Demonstrated experience overseeing quality management systems, audits, and corrective actions.
• Working knowledge of FDA’s Quality Management System Regulation (QMSR), 21 CFR Part 820, and ISO 13485.
• Ability to guide analytical and clinical evidence planning for IVD regulatory submissions.
• Experience managing multiple projects, client relationships, timelines, and budgets.
• Strong written and verbal communication skills, with the ability to translate complex requirements into clear recommendations and submission documents.

Preferred Qualifications

• Advanced degree in a relevant discipline and/or Regulatory Affairs Certification (RAC).
• Experience in a consulting or CRO environment, including proposal development and project scoping.
• Experience overseeing an ISO 9001 quality management system.
• Experience with De Novo requests, PMAs, Breakthrough Device designation requests, or EU IVDR conformity assessment.
• Experience in microbiology and infectious disease diagnostics, including antimicrobial susceptibility testing, bloodstream infections, respiratory infections, urinary tract infections, or sexually transmitted infections.
• Experience with molecular diagnostics, real-time PCR, sequencing, flow cytometry, or companion diagnostics.
• Experience reviewing software, cybersecurity, or AI/ML documentation for medical-device submissions.