Principal Regulatory Consultant

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🕒 February 2

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MB&A

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2019

⚕️ Healthcare Insurance

🎯 Recruiter

💊 Pharmaceuticals

Healthcare Insurance • Recruitment • Pharmaceuticals

MB&A is a boutique recruiting and consulting firm specializing in talent acquisition and business consulting for the medical device manufacturing sector. With over 20 years of experience, MB&A offers services including staffing, quality system audits, and regulatory support for software as a medical device (SaMD) products. The company prides itself on its deep industry expertise and commitment to connecting organizations with the right talent to enhance operational efficiency and meet regulatory standards.

📋 Description

• Lead and 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. • Support EU MDR and FDA regulatory compliance activities through hands-on execution. • Serve as primary liaison with FDA, Notified Bodies, and other health authorities, including preparation of responses to regulatory findings (e.g., FDA 483s). • Perform 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 readiness 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

• 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 preparation and submission of FDA and/or EU filings. • Recent hands-on Quality Engineering experience 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. • Strong technical writing and regulatory communication skills. • Certifications (Preferred) CQA, RAPS, or equivalent Regulatory/Quality certifications. • PMP (preferred).

🏖️ Benefits

• Competitive salary • Professional development opportunities