About the Company:
We are seeking an experienced a senior Quality leader to define and deliver the strategic direction of compliance function at company in West Yorkshire. As well as ensuring full regulatory compliance, you will oversee the quality and regulatory departments and support commercial growth and operational excellence. As a key member of the Senior Leadership Team, you will influence business strategy and lead a high-performing team.
Responsibilities:
- Set and deliver the compliance strategy aligned to business objectives
- Act as Responsible Person under MDR/UKCA, ensuring ongoing ISO 13485 compliance
- Lead and maintain Quality Management Systems and accreditations.
- Ensure audit readiness across the business and supply chain, managing audits and compliance programmes
- Oversee CAPA, change management, complaints analysis, and continuous improvement
- Collaborate with Sales, Marketing, Procurement, and key customers on regulatory and commercial matters
- Drive sustainability and ESG initiatives (e.g. ISO 14001)
- Lead, develop, and mentor UK-based compliance teams, embedding a “right first time” culture
Requirements:
- Proven senior leadership experience in compliance roles within regulated industries
- Strong knowledge of ISO 13485 and medical device or consumer health environments
- Experience building and managing robust QMS and compliance frameworks
- Commercially aware with the ability to balance risk and business needs
- Strong leadership, communication, and stakeholder management skills