Global Head of Quality Assurance and Regulatory

At Tobii Dynavox, we empower people with disabilities to do what they once did or never thought possible. We call this mission Power to Be You. Our assistive communication technology helps our customers express themselves, connect with the world, and pursue independence, whether through everyday activities like ordering food or extraordinary feats like running a company. Working at Tobii Dynavox, you’ll become part of a team that spans the globe, with offices in the US, Sweden, France, the UK, China, and beyond.

What you’ll do:

As the Global Head of Quality Assurance and Regulatory for a Class I/II Medical Device Manufacturer, you will be responsible for leading and overseeing all aspects of quality assurance and regulatory compliance across the organization's worldwide operations. This critical role involves developing and implementing robust quality systems, ensuring adherence to regulatory requirements, and driving a culture of continuous improvement to uphold the highest standards of product quality and compliance.

Key responsibilities/authority:

• Strategic Leadership: Develop and execute the global quality assurance and regulatory affairs strategy aligned with the overall business objectives. Provide leadership to the quality assurance and regulatory teams worldwide, fostering a collaborative and results-driven culture.
• Quality Systems Management: Implement and maintain robust quality management systems (QMS) to ensure consistent product quality and compliance with applicable regulations. Oversee internal and external audits, ensuring that corrective actions are identified and implemented.
• Supplier Quality Management: Ensure that the products or components sourced from external suppliers meet the required quality standards and comply with relevant regulations.
• Regulatory Compliance: Stay abreast of global regulatory requirements and industry standards, ensuring the organization's products and processes comply with all relevant regulations. Establish and maintain relationships with regulatory agencies and authorities globally.
• Product Registration and Approvals: Oversee the preparation and submission of regulatory filings, ensuring timely approvals for new products and modifications. Collaborate with cross-functional teams to facilitate product registration in various international markets.
• Quality/Industrialization/New Product Introduction Engineering: Guide the creation and deployment of manufacturing and test processes for new products, overseeing their market release. Utilize measurement and analysis to identify and address quality issues arising from field failures, collaborating with relevant stakeholders to ensure product excellence.
• Product Data and Document Management Administration: Oversight of product data creation and modification within enterprise systems, overseeing change control processes, document lifecycles, and version control. Collaborate with cross-functional teams to implement efficient data and document management processes, driving continuous improvement for streamlined documentation workflows.
• Risk Management: Develop and implement risk management strategies and processes to identify, assess, and mitigate risks associated with product quality and regulatory compliance.
• Continuous Improvement: Drive a culture of continuous improvement within the quality and regulatory functions, implementing best practices and ensuring lessons learned are applied across the organization.
• Training and Development: Provide training and development programs to enhance the skills and knowledge of the quality and regulatory teams. Foster a culture of quality and compliance throughout the organization.
• Budgeting and Cost Management: Develop and manage budgets for quality assurance and regulatory, and work to reduce costs wherever possible without sacrificing quality or service.
• Organizational Collaboration: Build and foster collaboration across the organization, including Sourcing, Supply Chain, Logistics, Product Management, Sales, Engineering, Marketing, Human Resources and Finance to ensure that Quality Assurance and Regulatory support the company's overall business goals.

We are looking for someone with:

• Bachelor's degree in a relevant scientific or engineering field
• Extensive experience in quality assurance and regulatory affairs within the medical device industry, with a focus on Class I and Class II devices.
• Extensive experience with quality management systems within a manufacturing environment, including ISO 13485:2016, ISO9001:2015, and DMEPOS.
• Experience working with environmental management systems and standards, ISO14001:2015, REACH, and WEEE.
• At least 10 years of experience in quality assurance, with at least 5 years in a leadership role.
• Proven track record of successful interactions with regulatory agencies and obtaining regulatory approvals.
• Experience applying verification and validation principles and techniques to electronic hardware and software product design.
• Excellent leadership, communication, and interpersonal skills, with the ability to work effectively with teams across multiple locations and functions.
• Experience working with and leading continuous improvement methodologies.
• Ability to travel internationally as needed.

Computer or technical skills:

• Familiarity with QMS software and tools is essential. Experience working with Master Control is a plus.
• Experience with systems that facilitate document control and management. This includes ensuring that documentation related to quality processes, procedures, and compliance is effectively maintained and accessible.
• Proficiency in working with data analysis tools to identify trends, patterns, and potential areas for improvement.
• Skills in statistical analysis and data visualization tools.
• Understanding of Enterprise Resource Planning (ERP) systems, as used to integrate quality processes with other business functions like supply chain and manufacturing.
• Use of Microsoft Office tools, including Word, Excel, PowerPoint, Teams, SharePoint and Power BI.