Director, Global Regulatory Affairs & Quality Assurance

The Director, Global Regulatory Affairs & Quality Assurance (RA/QA) provides executive-level leadership of the company’s global quality and regulatory functions. This role owns the global RA strategy, oversees all regulatory pathways across key markets (US, EU, UK, and RoW), and leads a multi‑site Quality Assurance organization ensuring enterprise-wide compliance with ISO 13485, IVDR/MDR, QMSR, and other applicable regulations. The Director drives alignment, harmonization, and operational excellence across Calibre Scientific’s global network of manufacturing and distribution sites.

To perform this job successfully, an individual must be able to perform the following satisfactorily (other duties may be assigned). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Own and execute the global RA strategy supporting market access, product lifecycle, and long-term business growth.
• Lead preparation, approval, and maintenance of global regulatory submissions, including Technical Documentation, 510(k), CE marking, UKCA, and international registrations.
• Provide strategic regulatory guidance to executive leadership, R&D, Operations, and Commercial teams.
• Coordinate with internal stakeholders to compile necessary data and documentation for submissions.
• Oversee regulatory intelligence and ensure proactive adaptation to evolving regulations.

• Lead and develop the global QA organization, including direct management of multi‑site QA leaders across manufacturing and operational facilities.
• Own the global Quality Management System (QMS), ensuring harmonization, compliance, and continuous improvement across all sites.
• Oversee internal and external audit programs, supplier quality management, CAPA effectiveness, and inspection readiness.
• Establish QA performance standards, KPIs, and reporting for executive leadership.

• Partner with Product, Operations, R&D, and Supply Chain leaders to ensure quality and regulatory requirements are integrated into product development and lifecycle management.
• Lead due‑diligence and integration activities related to mergers and acquisitions from a QA/RA perspective.
• Represent RA/QA in executive forums, contributing to strategic planning and risk management.
• Build, mentor, and develop a high‑performing global RA/QA team.
• Define organizational structure, succession plans, and talent development priorities across the function.
• Promote a culture of accountability, quality, and cross‑functional collaboration.
• Conduct training sessions to educate internal stakeholders on regulatory requirements, changes, and best practices.

Additional responsibilities may be requested as required by management and business needs.

To perform the job successfully, an individual should demonstrate the following competencies.

Demonstrates persistence and overcomes obstacles. Measures self against standard of excellence. Recognizes and acts on opportunities. Sets and achieves challenging goals. Takes calculated risks to accomplish goals.

Inspires the trust of others. Keeps commitments. Treats people with respect. Upholds organizational values. Works with integrity and ethically.

Exhibits good listening and comprehension. Expresses ideas and thoughts in written form. Expresses ideas and thoughts verbally. Keeps others adequately informed. Selects and uses appropriate communication methods.

Fosters quality focus in others. Improves processes, products, and services. Measures key outcomes. Sets clear quality requirements. Solicits and applies customer feedback.

Achieves win‑win solutions. Addresses divergent opinions. Displays ability to influence key decision‑makers. Pursues and wins support for ideas. Uses authority appropriately to accomplish goals.

Adapts strategy to changing conditions. Analyzes market and competition. Develops strategies to achieve organizational goals. Identifies external threats and…