Director of Quality Assurance & Regulatory Affairs
Location: Utrecht, Netherlands. Hybrid remote
Our client is a leading organization in the medical sector dedicated to improving healthcare through innovative products and solutions. With a commitment to quality, safety, and regulatory compliance, we are seeking a highly qualified and experienced Director of Quality Assurance & Regulatory Affairs to join our dynamic team.
Are you a hands-on manager who loves to create a climate that empowers team members to achieve their goals?
Does working in the Head Office in Utrecht, Netherlands, for one of the most progressive Medical Device Manufacturers sound exciting?
As the Director of Quality Assurance & Regulatory Affairs, you will play a crucial role in ensuring the highest standards of quality, safety, and compliance across our medical products and services. You will lead a talented team and collaborate with cross-functional departments, including R&D, quality assurance, research, and marketing to maintain and enhance our regulatory and quality systems and, to navigate the complex landscape of regulations and ensure that products meet all applicable standards.
Essential Functions:
- Provide quality oversight of manufacturing, testing, packaging, storage, and distribution processes.
- Develop and implement strategies for quality assurance, regulatory compliance, and continuous improvement.
- Ensure products are produced and tested following approved procedures and methods, complying with all applicable regulatory requirements and company policies.
- Develop and maintain a culture of quality and compliance throughout the organization.
- Establish and maintain relationships with regulatory authorities and industry associations.
- Stay current with industry trends, regulations, and best practices.
Qualifications:
- Bachelor's degree in a relevant field; advanced degree preferred.
- Minimum of 7 years of experience in quality assurance and regulatory affairs in the medical sector.
- Strong knowledge of FDA, ISO, and other regulatory requirements.
- Proven track record of successful regulatory submissions and approvals.
- Experience managing and developing a high-performing team.
- Excellent communication and interpersonal skills.
- Ability to think strategically and drive change within the organization.
- Detail-oriented with a commitment to ensuring the highest quality standards.
- Strong problem-solving and decision-making abilities.
Benefits:
Competitive salary and performance-based bonuses.
Comprehensive health, dental, and vision insurance.
Retirement savings plan with employer contributions.
Opportunities for professional development and growth.
How to Apply:
If you are a passionate and experienced professional with a dedication to quality and regulatory compliance in the medical sector, we encourage you to apply. Please send your CV detailing your relevant qualifications and experience
Join us in making a difference in healthcare through quality and innovation!
