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 (UK, US, EU, and RoW), and leads a multi‑site Quality Assurance organisation 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.

Essential Duties and Responsibilities: 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.

Global Regulatory Affairs Leadership:

• 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.

Global Quality Assurance Leadership:

• 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.

Cross-Functional & Strategic Responsibilities:

• 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.

People Leadership:

• 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.

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

Achievement Focus – 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.

Business Ethics – Inspires the trust of others. Keep commitments. Treats people with respect. Upholds organizational values. Works with integrity and ethically.

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

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

Impact & Influence – 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.

Strategic Thinking – Adapts strategy to changing conditions. Analyses market and competition. Develops strategies to achieve organizational goals. Identifies external threats and opportunities. Understands organization's strengths and weaknesses.

Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to other views. Gives and welcomes feedback. Puts success of team above own interests.

Team Leadership – Acknowledges team accomplishments. Defines team roles and responsibilities. Ensures progress toward goals. Fosters team cooperation. Supports group problem solving.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelor’s or Master’s Degree. 10 plus years of progressive RA/QA leadership experience in Medical Device, Diagnostics and or IVD’s. Expert knowledge of ISO 13485, IVDR/MDR, FDA QSR/QMSR and global regulatory frameworks. Demonstrated success leading global QA teams and managing multi-region portfolios. Proven experience influencing executive stakeholders and leading organizational change.

Language Ability:

Read, analyse and interpret business, professional, technical or governmental documents. Write reports, business correspondence and procedure manuals. Effectively present information and respond to questions from managers, customers and the public.

Mathematical Ability:

Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Compute rate, ratio and percent, and draw and interpret bar graphs.

Reasoning Ability:

Define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have knowledge of

• Demonstrated experience with Quality Management Systems.
• Strong data reporting capabilities, using Excel and other business intelligence tools.

Certificates and Licenses:

• Preferred certifications include Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC). ISO 9001 and/or ISO 13485 Lead Auditor certification strongly preferred. Additional certifications in GMP/GDP, Certified Pharmaceutical GMP Professional (CPGP), or Certified Medical Device Auditor (CMDA) are a plus.
• Active passport for global travel.

Supervisory Responsibilities: Direct report responsibilities of quality and regulatory affairs team globally, as defined by manager.