Job Description
The Head of Quality and Regulatory plays a pivotal role in ensuring the highest standards of quality and regulatory compliance within our organization. This position requires an individual with a strong background in quality management, excellent communication skills, and experience working with authorities in the medical environment.
Your Responsibilities:
* Implement quality management systems and ensure compliance with relevant regulations and standards.
* Represent the organization in local country QT (QM and RA) communities and related activities.
* Maintain relationships with legal authorities, trade associations, and certification bodies.
* Ensure full compliance to local and international regulations and standards affecting products and services.
* Monitor the regulatory environment to identify potential impacts on business operations.
* Develop and maintain direct relationships with country authorities responsible for medical devices and in-vitro diagnostic products.
Requirements and Qualifications:
* A master's degree in biomedical sciences, engineering, or other equivalent field.
* Strong quality management experience and communication with authorities in the medical environment.
* Ideal experience as an auditor.
* Solid knowledge and understanding of ISO13485 and European regulations.
* Excellent communication and people management skills.
* An analytical mindset and ability to work efficiently under pressure.
Benefits and Career Growth:
* A minimum of 39 days of annual leave.
* A competitive salary package, including fringe benefits such as a company car, fuel card, eco vouchers, meal vouchers, and insurance packages.
* A thorough onboarding process and various training courses.
* A pleasant working atmosphere with a focus on work-life balance and fun activities.
* A 'lifelong learning' culture that encourages continuous skill development.
About Us:
We are a company committed to diversity, equality, and inclusion. We consider all applications in accordance with these values and in full transparency.