Vice President of Regulatory Affairs & Quality

We are seeking a Vice President of Regulatory Affairs and Quality to provide enterprise leadership for regulatory affairs, quality assurance, and quality control in a manufacturing environment. This executive will establish and execute the global regulatory and quality strategy, ensure that products and operations meet applicable requirements, and build scalable systems that support innovation, commercialization, and sustainable growth.

MUST HAVE:
Experience in directing the preparation, submission, and maintenance of regulatory dossiers, registrations, notifications, and approvals across applicable jurisdictions and product categories.

This hands-on executive position requires the ability to translate complex regulatory and quality requirements into practical business strategies and to lead effectively across scientific, technical, manufacturing, commercial, and corporate functions. The Vice President will serve as a trusted advisor to the executive team.

• Define and lead the global regulatory strategy for the company's product portfolio, innovation pipeline, market expansion, and lifecycle management activities.
• Direct the preparation, submission, and maintenance of regulatory dossiers, registrations, notifications, and approvals across applicable jurisdictions and product categories.
• Advise executive leadership and cross-functional teams on regulatory pathways, emerging requirements, business risk, and the regulatory implications of strategic decisions.
• Establish effective relationships with regulatory authorities, scientific experts, external organizations, and industry associations, and represent the company in relevant regulatory and scientific forums.
• Maintain an enterprise horizon-scanning process for regulatory and scientific developments, assess their impact, and ensure timely risk mitigation and communication to business leaders.
• Provide regulatory leadership throughout product development and commercialization, including claims, labeling, specifications, customer requirements, and market access.

• Provide executive leadership, direction, and development for the Quality Assurance and Quality Control functions, including organizational design, talent planning, and succession readiness.
• Own the enterprise Quality Management System and ensure it is scalable, risk-based, and compliant with applicable laws, regulations, industry standards, and customer requirements.
• Establish quality governance, policies, procedures, records, and management-review processes supporting product development, technology transfer, manufacturing, release, distribution, and post-market activities.
• Oversee product quality, laboratory controls, supplier quality, change control, deviations, investigations, corrective and preventive actions, complaints, and document control.
• Direct internal, supplier, customer, and regulatory audit programs; ensure timely remediation of findings; and maintain organizational readiness for inspections.
• Serve as the senior quality authority for product disposition, significant quality events, regulatory inspections, recalls, and other matters requiring independent quality judgment and escalation.

• Present regulatory and quality strategy, performance, material risks, resource needs, and improvement priorities to executive leadership and other key stakeholders.
• Build a culture of quality, compliance, accountability, and continuous improvement across the organization through visible leadership, education, and cross-functional partnership.
• Establish and monitor key performance and risk indicators, management dashboards, and operating reviews to measure program effectiveness and drive…