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Head of Quality & Regulatory Affairs

Head of Quality & Regulatory Affairs

W TalentVaud, Switzerland
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Head of Quality & Regulatory Affairs

Head of Quality & Regulatory Affairs

W TalentVaud, Switzerland
Il y a 3 jours
Description de poste

Our client is a leading global company based in the Canton of Vaud, Switzerland, specializing in the development of high-precision medical devices.

With a strong focus on innovation, quality excellence, and regulatory compliance, the company is committed to advancing patient care through cutting-edge technologies. They have built a reputation as a trusted partner for healthcare professionals worldwide and continue to drive growth across international markets.

As part of their expansion, they are looking for a Head of Quality to further strengthen their operations and continue to ensure the delivery of high-quality, compliant medical devices.

Your Mission

As the Head of Quality & Regulatory Affairs, you will :

  • Lead with Purpose : Be the driving force behind the strategic development and execution of the Quality Policy and Management System, aligned with ISO 13485, FDA QSR 21 CFR 820, and other global standards.
  • Ensure Excellence : Spearhead quality assurance for product development, manufacturing, and market release while maintaining compliance with regulatory requirements.
  • Shape the Future : Develop and implement strategies to uphold the reputation for product reliability as new products are launched and the company expands into new regions.
  • Inspire and Motivate : Lead, mentor, and grow a high-performing quality team to meet the company’s ambitious goals.

Key Responsibilities

Strategic Leadership

  • Act as the Management Representative and Person Responsible for Regulatory Compliance (PRRC), ensuring robust quality systems and regulatory adherence.
  • Collaborate with cross-functional teams to support the seamless launch of new products and geographic expansion.
  • Define and implement a forward-thinking regulatory strategy to support business growth across all units.

    • Operational Excellence

  • Establish and enhance quality systems, ensuring continuous improvement and alignment with global standards.
  • Manage third-party audits (ISO, FDA) and lead internal and supplier quality audits.
  • Oversee product compliance, risk management, and supplier validation to ensure product reliability and customer satisfaction.

    • Team Development

  • Lead and inspire the quality team, fostering a culture of accountability, innovation, and excellence.
  • Provide training and promote regulatory awareness across the organization to build quality-conscious teams.

    • Performance Management

  • Analyze quality-related data, oversee non-conformity resolutions, and drive corrective actions to improve product quality and minimize costs.
  • Report on key performance indicators (KPIs) and present findings to top management.

    • Customer and Market Focus

  • Partner with internal stakeholders to address client quality concerns and ensure post-market surveillance compliance.
  • Support global growth by facilitating quality systems for new warehouses and country launches.

    • What We’re Looking For :

  • Proven experience in quality management within the medical device industry or a regulated healthcare environment.
  • Expertise in ISO 13485, FDA regulations, and risk management methodologies.
  • Strong leadership skills, with a history of building and inspiring high-performing teams.
  • Strategic thinker with a hands-on approach to problem-solving and process improvement.
  • Exceptional communication skills and the ability to collaborate across diverse teams and functions.
  • Academic background : Master’s degree or engineering qualification in a relevant field (e.g., engineering, quality management, life sciences, or similar).

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