Created in 2013, Wishbone is an innovative start-up located in Flemalle (Liege). Wishbone is engaged in the development of intraoral bone regeneration biomaterials. The company has launched its industrialization and production activities in a brand new production unit and has successfully reached ISO 13485 certification.
The goal of Wishbone is to develop superior bone graft substitute products with breakthrough technologies and innovative procedures, and thus improve patient well-being and contribute to a better environment. The company will launch its forst commercial product and several other innovative products are under development. For more information please visit: www.wishbone-biotech.com
To support this challenging development, we are looking for a (m/f):
Quality Assurance and Regulatory Affairs Manager
As a Quality Assurance and Regulatory Affairs Manager, you are responsible for managing the company Quality Management System and its related activities. You are also responsible for the Regulatory Affairs Management. You ensure the company and the products are compliant with the appropriate standards and regulations. You provide support in the Quality Management System maintenance and improvements. This includes the development of systems, policies/procedures and programs to ensure compliance with the EU and FDA regulations, ISO standards, and other international requirements.
You have a cross-functional role, directly manages a small team of QA/RA Associate and Product Specialist and interact with all departments and with the top management.
Your main responsibilities are :
- Managing the Quality Management System according to the EU ISO 13485, the US FDA 21 CFR Part 820 and any other relevant regulatory requirements in accordance with the Quality Policy.
- Ensuring that required processes of the Quality Management System (QMS) are documented, established, implemented and maintained.
- Assuring that products have been supplied, manufactured, analyzed and released according to specifications and approved SOP’s and to appropriate standards and regulations.
- Organizing and documenting the Management Review according to the company QMS. Recommending and driving improvement.
- Performing supplier audits, internal and external audits and interacting with suppliers and customers to deal with non-conformities and drive continuous improvement.
- Supporting activities for CE marking and FDA approval certification of products as well as maintaining the documentation up to date when changes to the product occur, dealing with notifications and amendments when required.
- Managing materiovigilance activities including incident and post-market surveillance reporting.
- Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Reporting to the management on the effectiveness of the Quality Management System and any need for improvement of the company organization.
- Scientific Master’s degree, or equivalent through experience.
- At least 5 years of experience in QA management positions in the medical devices industry.
- Strong understanding of regulations and guidelines governing medical devices (e.g. CFRs, ISO 13485, MDD, MDR).
- Strong leadership, project management and communication skills together with hands-on and pragmatic mind-set.
- Ability to work in a start-up environment where accuracy, accountability, quality, safety and timeliness are essential.
- Highly collaborative, self-motivated and team-oriented individual in a company setting.
- Excellent oral and written communication skills in French and English.
- The opportunity to join an innovative medical device company, a fast-growing start-up environment where teamwork, results and patient care are very important.
- A challenging and diversified position in a dynamic, young and nice
- To work in a human size, respectful and professional environment.
- An attractive compensation package in line with the position responsibilities and your experience.