Our client is a young start-up that develops IVD solution for the Immuno-Hematology-Transfusion field.
The company is currently completing technical development and clinical validation of its first device to be launched. They will initiate in 2019 the implementation of its industrialization strategy. Therefore, they are looking for a QA/RA Manager.
You are looking for a professional challenge that allows you to work in an innovative start-up in order to develop and implement Quality System and Regulatory Strategy?
You want to bring the competences that you have acquired in the field of quality (operations and strategy), especially in Medical Devices and or IVD? Developing a project from scratch is motivating for you?
Plus One can offer you this great challenge:
Your key responsibilities:
Quality related activities:
• Accountable for development, implementation and QMS compliance
• Drive actions plan to get ISO13485 certification and renewal, including but not limited to
• Participate on cross-functional developmental teams including project planning and design review activities
• Define quality metrics relevant for Management Review
Regulatory related activities:
• Accountable for development and implement regulatory strategies and plans for products in line with company business strategy
• Prepare and submit regulatory submissions to Europe (CE Mark), primary focus
• Prepare and submit international regulatory submissions, as international markets develop. This includes but is not limited to USA, Canada, Asia, etc.
• Communicate directly with regulatory agencies on all regulatory issues, including product vigilance and reporting
• Monitor regulations, guidance and standards and communicate applicable requirements to affected products
• Evaluate impact of product and system changes on regulatory status for both EU and relevant international countries/regions
• Maintain corporate regulatory files
• Master in Engineering, Science or technical discipline, or equivalent experience.
• 5-8+ years in an QA Manager role. QA manager in full medical device manufacturing and product development is an asset
• 5-8+ years experience in Regulatory Affairs; experience in the medical device industry is a strong plus
• Experience in QMS management in ISO Certified environment. Knowledge and experience of ISO13485 QMS is a plus
• Experience in performing audits in ISO Certified environment
• Expertise in working within Medical Device Regulations including Quality System Regulation 21 CFR Part 820, ISO13485 QMS , EU MDD/MDR, Regulation IVD 2017/746, MDSAP, Canadian Regulations is a strong plus
• Experience interacting with Notified Bodies regarding regulatory matters and with national competent authorities in EU is a plus
• Experience and/or exposure to transfusion, biologics (antibodies/antigens), microfluidics, micro-electronics, micro-injection molding and/or centrifugation fields is a plus
• Experience of “Matrix Requirements” ALM/QMS web platform is a plus
• Excellent organizational skills and keen attention to detail
• Communicates clearly and concisely with diverse audiences, in both oral and written contexts, and is comfortable giving and receiving feedback.
• Fluent in French and English. High quality written English is a must.
• Rigorous, passionate, autonomous, dynamic and excellent team skills
• Ability to structure processes and lead team
• Hands-on problem solving and proactive attitude
• Ability to work in less structured environments (startup)
• Past experience in startup with entrepreneurial mindset, is definitively a plus
• Resilience; calm and deliberate under conditions of stress
• Open mind, enthusiastic, sense of innovation and literature reading and update.
The opportunity to join an innovative company and a new team facing ambitious challenges. The opportunity to endorse various responsibilities and with the opportunity to be coached (development plan).