Director of Quality & Regulatory Compliance

Overview

ROMTech is a Class II medical device manufacturer committed to delivering safe, compliant, high-quality products that improve patient recovery outcomes. The Director of Quality & Regulatory Compliance is the senior owner of ROMTech’s Quality Management System (QMS) and FDA regulatory compliance—responsible for ensuring the company is continuously FDA audit-ready, not “audit-ready when we scramble.”

This leader serves as the primary FDA regulatory contact and internal compliance authority, owning the systems, governance, and execution required to maintain a robust QMS. This role partners cross-functionally with Manufacturing, Engineering, Supply Chain, IT, and Customer teams to prevent issues, drive corrective action, and uphold product quality and regulatory compliance end-to-end.

What Success Looks Like

• ROMTech is inspection‑ready every day: documentation, training, CAPAs, complaints, calibration, audits, and records are complete, current, and defensible.
• FDA interactions are well‑managed, timely, and professional (inspections, submissions, responses).
• Quality signals (complaints, nonconformances, audit findings) are trended, acted on, and reduced through systemic fixes.
• The organization knows “what good looks like” through clear procedures, accountability, and routine management review.

Key Responsibilities

FDA Regulatory Leadership & Inspection Readiness

• Serve as ROMTech’s FDA regulatory contact and lead all FDA inspection hosting, coordination, and response activities.
• Maintain FDA establishment registration and related accounts (e.g., GUDID, QS/portal accounts as applicable).
• Lead regulatory strategy and manage submissions for FDA clearances/updates as needed (in partnership with Engineering/Clinical/Leadership).
• Ensure labeling, intended use positioning, and regulatory commitments are reflected in controlled documentation and execution.

QMS Ownership (ISO‑aligned, FDA‑compliant)

• Own the QMS framework: procedures, controls, governance cadence, escalation paths, and continuous improvement.
• Lead Management Reviews and ensure performance data and actions are captured, tracked, and closed.
• Ensure compliance across core subsystems: document control, training, CAPA, complaints/MDR, audits, calibration, nonconformance, and supplier quality interfaces.

CAPA Leadership

• Own the CAPA process end‑to‑end, including board cadence, prioritization, effectiveness checks, and trend reporting.
• Chair (or designate/chair) a CAPA Review Board; ensure corrective actions address systemic root causes, not symptoms.

Complaint Handling & MDR

• Ensure a compliant complaint handling program with clear intake, investigation, documentation, closure, and trending.
• Oversee MDR decisioning and submissions (with Quality Engineering support), ensuring timeliness and defensibility.
• Use complaint trends to drive CAPAs and quality improvements.

Internal Audits

• Build and maintain the internal audit schedule, train/assign auditors, and ensure audits are executed and closed with appropriate CAPAs.
• Track audit performance, systemic gaps, repeat findings, and closure quality.

Document Control & Records Integrity

• Own the document control system outcomes (accuracy, integrity, release discipline, archival discipline), including ensuring DHRs/quality records are complete and retrievable.
• Partner with Document Control resources (and/or Standards Manager) to ensure the system is scalable and inspection‑proof.

Training System Governance

• Ensure QMS training requirements are defined, assigned, tracked, and audit‑ready (completion evidence, role‑based matrices, re‑training triggers).
• Drive training compliance as a quality system, not an HR checkbox.

Calibration & Measurement Systems Oversight

• Ensure an effective calibration program (logs, schedules, external calibration coordination, in‑house calibration execution discipline).
• Ensure measurement equipment and inspection tools remain within control and traceability expectations.

Product Quality Oversight (QC Interface)

• Provide governance and escalation for the product inspection program (incoming, in‑process, final), NCR/NCMR flow, and MRB dispositions—ensuring systemic issues trigger CAPA and supplier actions.
• Ensure nonconforming material is controlled, trended, and prevented through upstream fixes.

Design Quality / Risk / Quality Engineering Partnership

• Ensure quality participation in risk activities (e.g., hazard analysis/FMEA support), verification/validation quality controls, and structured problem‑solving (8D/5‑Why/DMAIC), in partnership with Quality Engineering and Engineering leadership.

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