Principal Regulatory Consultant (1099)

MB&A; Offre d’emploi; Hybride; EUR 100 000 - 125 000; Plein temps

Résumé du poste

A consulting firm specializing in regulatory affairs is seeking a Principal Regulatory Consultant to lead global regulatory strategies for medical devices and biologics. The role involves preparing and submitting regulatory filings, driving compliance activities with FDA and EU standards, and performing quality engineering. Ideal candidates have over 15 years of experience in regulatory affairs, with strong regulatory communication skills. This position offers an opportunity to work on meaningful engagements that make a significant impact in the regulatory landscape.

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.
• Strong working knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14971.

Responsabilités

• Lead and execute global regulatory strategies for Class II–III medical devices.
• Prepare and submit regulatory filings including 510(k) and PMA.
• Drive EU MDR and FDA compliance with hands-on execution.

Connaissances

Regulatory Affairs

Quality Engineering

Technical Writing

Regulatory Communication

FDA Regulations

EU MDR

ISO Standards

Description du poste

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.