Head of Regulatory Compliance and Quality Assurance

2 weeks ago

Phoenix, Arizona, United States Growing medical company via The Walstrom Group, Inc. Full time

The Director of Regulatory Compliance and Quality Assurance plays a pivotal role in collaborating with the executive team, including the President and the head of Regulatory Affairs, to establish and execute a comprehensive global compliance strategy for Regulatory Affairs and Quality Assurance. This position encompasses the implementation and oversight of the organization’s quality management system, ensuring adherence to industry standards and regulatory mandates while engaging with both internal and external stakeholders to guarantee that products align with the highest applicable standards.

Key Responsibilities:

Quality Assurance Management

  • Oversee the establishment and maintenance of a robust Quality Management System (QMS) that complies with international regulatory standards and protocols, including but not limited to ISO 13485, FDA Quality Systems Regulations (QSR), and Medical Device Directive (MDD).
  • Direct the strategic planning and management of QA systems to facilitate continuous design, development, production, and post-market surveillance of safe and reliable products, consistent with established regulatory requirements.
  • Implement and sustain an electronic QMS framework for managing quality system documentation, including quality system, complaint handling, CAPA, audits, and training records.
  • Enhance the effectiveness of the Quality System by developing and deploying efficient processes and tools to identify, investigate, report, measure, and address compliance challenges.
  • Refine and execute training protocols in accordance with regulatory standards; create processes to uphold internal compliance with ongoing QMS requirements.
  • Maintain current knowledge of relevant Quality System requirements and industry best practices, advising the management and RA/QA leadership teams on significant changes and potential risks.
  • Foster positive and proactive relationships with regulatory bodies to ensure substantial compliance and facilitate global operations in the marketing and distribution of products and services.

Leadership and Team Development

  • Provide strategic leadership, oversight, and direction, effectively supervising, coaching, and mentoring team members.
  • Encourage a collaborative team environment through transparent communication of company strategies, priorities, and updates.
  • Lead departmental initiatives in the adoption of Lean methodologies and continuous improvement processes.
  • Align the quality function’s needs with those of leadership teams across the organization.
  • Engage with customers on quality and regulatory matters, as well as business development opportunities.

Qualifications and Skills:

  • Bachelor’s degree in a technology or science-related field is preferred.
  • A minimum of 8 years of experience in Regulatory Affairs and Quality Assurance, ideally within the medical device sector or another FDA-regulated environment. Experience with medical device license applications for the US, Europe, and Canada is advantageous.
  • At least 5 years of experience in establishing, implementing, and maintaining quality systems that meet CMDR/ISO 13485, FDA/QSR, and MDR requirements.
  • Experience in a lean manufacturing setting is preferred.
  • Demonstrated leadership abilities, technical proficiency, and problem-solving capabilities.
  • Proven track record of working directly with domestic and international regulatory authorities.
  • Comprehensive knowledge of QSR, ISO, CE, and QA principles.
  • Experience managing regulatory processes in regions such as Japan, China, India, and the Middle East is a plus.
  • Expertise in navigating FDA requirements is essential.
  • Exceptional communication skills, both verbal and written.
  • Ability to manage ambiguity and shifting priorities while proposing effective solutions.

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