Healthcare is our passion. We are growing Oncomfort Digital Sedation™ to clinical relevant standard of care with high quality standards and the proper regulatory approvals. As Quality & Regulatory Manager, you ensure the setting and implementation of the regulatory strategy and the maintenance of the quality management system. You organise and ensure the monitoring of quality and ensure the staff awareness to applicable regulatory and quality management system requirements. You implement and maintain the regulatory processes needed to meet the requirements of the Medical Device Regulations.
You directly report to the CEO.
We offer you to be part of an exciting innovation in healthcare with a competitive package, based on market-access driven results and the opportunities to grow with a great team.
Your main duties and responsibilities are to:
- Establish, manage and maintain a quality assurance system according to ISO13485 and all other standards or regulations deemed necessary by the company, esp. CE and FDA.
- Manage the projects related to product quality.
- Monitor the efficiency of the system, detect the needs for improvement and report them to the Executive Management.
- Alert the Executive Management in case of quality deviations and organise field actions or recalls.
- Contribute to the development of quality objectives.
- Ensure the follow-up and analysis of customer and supplier complaints.
- Ensure the traceability of products and the monitoring of information related to production lots.
- Release product lots (signing of the conformity certificates).
- Ensure internal audit and training programmes are set-up and managed as appropriate.
- Ensure efficient Management Reviews.
- Ensuring the responsibility of the materiovigilance process.
You hold a Master's degree and have 3 to 5 years of experience in Quality Assurance & Regulatory in Class I and II medical devices and digital health. You have significant experience in regulatory filing and monitoring processes.
Your skills and competencies
Your main skills and competencies are related to punctual and responsible management of quality and regulatory processes, and business-oriented approach to the subject.
- Good knowledge of the ISO13485 standard and CE Marking related regulation.
- Excellent oral and written communication skills in English.
- Ability to teach and train the staff on quality and regulatory-related topics.
- Excellent organisational skills.
- Excellent teamwork skills.
- Strong problem-solving skills.
- Skilled at working effectively with cross functional teams.