MB&A
2 - 10 employees
Founded 2019
🏥 Healthcare
🎯 Recruiter
💼 Consulting
Healthcare • Recruitment • Consulting
MB&A is a boutique recruiting and consulting firm focused on the medical device manufacturing industry. They provide talent acquisition, staffing, and recruiting services as well as quality and regulatory consulting including quality system audits, audit and compliance services, management review preparation, remediation support, Quality Due Diligence, operations and engineering support, SaMD/SiMD quality systems management, start-up partnerships, and project management. MB&A leverages over 20 years of experience conducting quality system audits for medical device manufacturers and suppliers worldwide and partners with machine shops for manufacturing and sourcing support.
Principal Regulatory Consultant
Job not on LinkedIn
🕒 February 2
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MB&A
2 - 10 employees
Founded 2019
🏥 Healthcare
🎯 Recruiter
💼 Consulting
Healthcare • Recruitment • Consulting
MB&A is a boutique recruiting and consulting firm focused on the medical device manufacturing industry. They provide talent acquisition, staffing, and recruiting services as well as quality and regulatory consulting including quality system audits, audit and compliance services, management review preparation, remediation support, Quality Due Diligence, operations and engineering support, SaMD/SiMD quality systems management, start-up partnerships, and project management. MB&A leverages over 20 years of experience conducting quality system audits for medical device manufacturers and suppliers worldwide and partners with machine shops for manufacturing and sourcing support.
📋 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) • MDR and Complaint Handling Training
🏖️ Benefits
• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options
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