Role overview

Qualifications

15+ years of experience in Regulatory Affairs and Quality within the medical device or life sciences industry
Demonstrated hands-on regulatory submission experience within the last 5 years, including direct preparation and submission of FDA and/or EU filings
Recent hands-on Quality Engineering experience within the last 5 years, supporting QMS, CAPA, risk management, or inspection readiness
Strong working knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14971, and related global standards

Responsibilities

Lead and personally execute global regulatory strategies for Class II–III medical devices, biologics, and combination products
Prepare, author, and submit regulatory filings including 510(k), PMA, IDE, Technical Files, Clinical Evaluation Reports, and Q-subs, with direct involvement
Serve as primary liaison with FDA, Notified Bodies, and other health authorities, including direct preparation of responses to findings (e.g., FDA 483s)
Perform hands-on Quality Engineering activities in support of regulatory objectives, including CAPA, risk management, and QMS support

Key facts

Remote from: Anywhere
Freelance
Regulatory Analyst
English

Hard skills

Clinical Data Analysis FDA Regulations Process Analysis Regulatory Compliance Registration Authority ISO 13485 Standard DOT (Department Of Transportation) Inspections Auditing Risk Management ISO 13485 Standard Cross-Functional Collaboration Regulatory Compliance

Other skills

Training And Development
Leadership

About the company

MB&A

MB&A is a boutique recruiting and consulting firm committed to delivering top-tier talent acquisition services and business consulting to life sciences companies. We are revolutionizing the outsourced recruiting experience by leveraging our team of industry veterans to identify top talent. We also provide consulting and crisis management support. Our consultants can tackle almost any area of Supply Chain, Quality, and Regulatory Compliance. We specialize in manufacturing transfers, validations, process improvements, and operational quality. We bring calm to quality and regulatory crises by leveraging our 20+ years of experience and best-in-class processes. Recalls, Audit Support, Warning letters, and 483 responses are our core competencies. We can quickly mobilize to support you anytime and anywhere. For more information, call us at 800-367-1020 or visit our website and click "Get Started."

Company details

Company size2 - 10

Links

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Job description

This is a remote position.

Position Summary

MB&A is seeking a hands-on Principal Regulatory Consultant who combines recent, real-world regulatory submission experience with practical Quality Engineering execution. This role is designed for consultants who actively prepare and submit filings, engage directly with regulatory bodies, and remain involved in hands-on quality activities—not purely advisory leadership.

Key Responsibilities

Lead and personally execute global regulatory strategies for Class II–III medical devices, biologics, and combination products.
Prepare, author, and submit regulatory filings including 510(k), PMA, IDE, Technical Files, Clinical Evaluation Reports, and Q-subs, with direct involvement.
Drive EU MDR and FDA compliance activities with hands-on execution, not oversight alone.
Serve as primary liaison with FDA, Notified Bodies, and other health authorities, including direct preparation of responses to findings (e.g., FDA 483s).
Perform hands-on Quality Engineering activities in support of regulatory objectives, including CAPA, risk management, and QMS support.
Maintain and support QMS infrastructure, including establishment registration, GUDID, and compliance with 21 CFR 820/QMSR and ISO standards.
Support audit and inspection activities through direct participation and execution.
Develop regulatory and quality training materials and support cross-functional teams.
Serve as PRRC under EU MDR where applicable.

Requirements

Minimum Qualifications

15+ years of experience in Regulatory Affairs and Quality within the medical device or life sciences industry.
Demonstrated hands-on regulatory submission experience within the last 5 years, including direct preparation and submission of FDA and/or EU filings.
Recent hands-on Quality Engineering experience within the last 5 years, supporting QMS, CAPA, risk management, or inspection readiness.
Strong working knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14971, and related global standards.
Proven experience interfacing directly with FDA and Notified Bodies.
Excellent technical writing and regulatory communication skills.

Certifications (Preferred)

CQA, RAPS, or equivalent Regulatory/Quality certifications
PMP (preferred)
MDR and Complaint Handling Training

Benefits

Why Join MB&A as a Consultant?

MB&A offers senior consultants the opportunity to work on meaningful, high-impact regulatory engagements that require both strategic insight and hands-on execution. Our projects are curated to align with consultant expertise while delivering measurable regulatory and quality outcomes for our clients.

Salary: $100 – $125/hr