Principal Regulatory Consultant (1099)

Location: Remote / Onsite Client Support as Needed

Industry: Medical Devices / Orthopaedics / Combination Products

Position Summary:

MB&A is actively seeking a Principal Regulatory Consultant with deep domain expertise to serve as a trusted advisor and hands-on contributor for client engagements across the med tech and life sciences sector. This role is ideal for a consultant who combines sharp regulatory intelligence with real-world execution—someone who has navigated everything from early-stage strategy to global submissions and post-market compliance.

As a Principal Regulatory Consultant, you will architect regulatory pathways, mentor cross-functional teams, and deliver submission-ready documentation for innovative and legacy products alike.

Key Responsibilities:

• Lead development and execution of global regulatory strategies for Class II-III medical devices, biologics, and combination products.
• Author, review, and manage regulatory submissions including 510(k), PMA, IDE, Technical Files, Clinical Evaluation Reports , and pre-submissions (Q-sub).
• Develop and implement EU MDR, FDA, ISO 13485, and other global compliance frameworks.
• Act as liaison with Notified Bodies, FDA , and other global health authorities, including direct interface and formal response submissions (e.g., 483s).
• Maintain and support QMS infrastructure, including GUDID, establishment registration, and compliance with 21 CFR 820/QMSR , ISO 13485 , and ISO 14971 .
• Oversee clinical strategy development, including clinical study protocols , IDEs, and post-market surveillance.
• Serve as a compliance lead during audits and inspections; conduct internal/external audits per FDA and ISO requirements.
• Develop and maintain regulatory training materials and facilitate education for cross-functional client teams.
• Serve as the Person Responsible for Regulatory Compliance (PRRC) where applicable under EU MDR.
• Provide thought leadership on industry trends, regulatory advocacy, and regulatory intelligence.

Requirements

Minimum Qualifications:

• 20+ years of progressive experience in regulatory affairs, with leadership roles in both start-up and global med-tech companies.
• Strong working knowledge of FDA regulations , EU MDR , ISO 13485 , ISO 14971 , and other applicable international standards.
• Demonstrated success authoring and leading regulatory submissions across a wide product spectrum, including orthopaedic implants, biologics, and diagnostics.
• Experience in interfacing with FDA (including PMA/IDE/510(k)), Notified Bodies, and managing direct responses to findings, including FDA 483s .
• Proven experience as a Compliance Officer, Management Representative , or PRRC is highly desirable.
• Working understanding of clinical research processes including IDE development and GCP/ISO 14155 compliance.
• Skilled in integrating regulatory strategy with business operations, including product development, clinical, marketing, and manufacturing.
• Exceptional technical writing and regulatory communication skills.

Certifications (Highly Desirable):

• CQE, CQA, RAPS or equivalent Quality/Regulatory certifications
• Project Management Professional (PMP) – preferred
• Medical Device Reporting (MDR) and Complaint Handling Training

Education:

• Bachelor’s or Master’s Degree in Mechanical Engineering, Biomedical Engineering, Engineering Science, or related discipline.