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Director, Compliance Engineering

Employer
Natus Medical Incorporated
Location
Middleton
Salary
Competitive

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The Director of Compliance Engineering is a senior leader within our global R&D organization who ensures activities and deliverables of the R&D team adhere to Natus Design Controls and the relevant Quality, ISO and Regulatory Standards. You can expect to apply deep knowledge of design controls and global regulations such as US FDA CFR 820 and EU MDR. As a leader, you can expect to coordinate the activities and training of the R&D team to ensure that the design documentation is compliant to regulations. You'll provide hands-on leadership for various projects including NPI, Maintenance, Sustaining, DHF Remediation, and CAPAs to ensure the R&D team is set up for success.

About the Team:

You can expect to build and grow a team of up to 10 direct reports (R&D Quality Engineers) who will work on various R&D projects with project teams. You can expect to provide indirect/matrixed supervision to the entire R&D team as it relates to compliance and design controls.

Main Responsibilities

Drive the R&D Compliance Strategy for the entire Natus Product families against the regulations and regulatory changes including but not limited to US FDA CFR 820, EU MDR, Risk Management, Bio-Compatibility, Usability Engineering, Mobile Applications/Cloud and IoT
Drive cross functional alignment between R&D, QA, RA, Product Management and Operations leadership to ensure Natus has one common understanding of the regulations, regulatory changes, directives and guidance
Disseminate the ever changing regulatory landscape to appropriate and necessary updates to Natus Design Control Procedures and Work Instructions. Works with Systems Engineering Manager and QA Manager to drive these procedural changes and appropriate implementation timing
Perform assessment of Natus products against the regulations/changes to regulations (US FDA, EU MDR, CFDA, ISO and IEC) and provides a strategy and roadmap for DHF Remediation, TDF Remediation and Product Remediation
Build and mentor a team of R&D Quality Engineers whose primary responsibility is to ensure that the design documentation produced by the R&D project team is of high quality and compliant to Natus Design Control procedures
Take ownership of the Remediation project strategy and provides the compliance supervision to the project teams to ensure a cross functional alignment on deliverables and execution strategy
Provide or coordinate in-class and hand-on training to the R&D project team members (both internal and off-shore/on-shore external contractors)
Work closely with the R&D Functional Managers to ensure that all Natus R&D teams (Hardware, Systems, Software, Verification, Validation, Sustaining, PMO and Labelling) are familiar with, trained on and follow all Design Control and Compliance procedures related to their jobs which can affect the quality of products or services provided to our customers and that changes to procedures are reviewed, approved and validated prior to implementation
Attend all external audits (FDA, MDSAP etc) and provides the necessary support by working closely with Systems Manager, other R&D Managers and Design SMEs
Create key performance indicators (KPI) to assess R&D projects and CAPA execution as it relates to compliance procedures and design controls ; Uses KPIs to make continuous process improvements with R&D
Travel: up to 50% domestic or international travel

Qualifications

Bachelor's degree in Engineering, Life Sciences or related discipline required; Master's degree preferred
10+ years' experience of successful demonstrated experience leading Compliance Engineering, Quality Assurance/Quality Engineering or Regulatory Affairs within medical device/diagnostics industry
Proven deep knowledge and successful application of following regulations and standards -- FDA Quality System Regulations CFR 820, EU MDR 2017/745, Design Controls, Current Good Manufacturing Practices, ISO 13485, ISO 14971, EN 62304, IEC 60601, IEC 62366, ISO 10993
Ability to understand and evaluate complex data and regulations and communicate compliance risks with clarity and integrity
Superior communication, collaboration and negotiating skills. Ability to achieve buy-in and understanding across different functional areas within the company and influence the senior leadership team and the rest of the organization
Effective communication skills, superior written communication and presentation skills
Extensive experience working with global teams and offshore partners
Demonstrated strong sense of urgency and ability to manage conflicts
PMP certification preferred, but not required

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