MB&A
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.
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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.
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