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.  

Required Qualifications 

• 5–10 years in Quality / Compliance in medical devices (Class II strongly preferred). 

• Demonstrated ownership of an FDA-compliant QMS (21 CFR 820 / ISO 13485 environment). 

• Direct experience leading FDA inspections and managing responses (483s, observations, remediation plans if applicable). 

• Strong working knowledge of: 

• CAPA, complaint handling, MDR, internal audits 

• Document control and record integrity (incl. DHR/traceability expectations) 

• Calibration systems and measurement control 

• Nonconformance/MRB governance and trending 

• Proven ability to translate regulatory requirements into practical, adoptable operations.