Directory of Quality and Regulatory
Job Summary:
The Director of Quality Assurance and Regulatory will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products.
You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company. Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant regulations and standards.
Duties/Responsibilities:
- Contact person for top management
- Management and responsibility of the quality management and regulatory team
- Further development of the existing QM system ensuring the requirements of the US product approvals
- Ensure that the QM system meets all the necessary requirements for marketing our products in the USA
- Responsibility for all operational processes such as change management, design process, risk management, supplier qualification, validation, CAPA nature
- Other duties as assigned
Required Skills/Abilities:
- Excellent communication and leadership skills, team spirit and transformational leadership style
- Very good knowledge of the regulatory requirements for medical devices in the USA
- Ability to present and communicate complex issues in a structured and generally understandable manner
- Willingness to work, initiative, assertiveness and resilience
- Willingness and ability to adapt to the changing needs of a growing business
Education and Experience:
- Completed degree in engineering, natural sciences or comparable qualification with experience in quality management
- Experience in managing projects
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.