Quality & Regulatory Manager and for Medical Device
vor 2 Wochen
Want to have an impact on the life of hundreds of millions of patients? Become the Q&R manager at Lumendo
About us
Lumendo, founded in 2018 and ISO 13485 certified, aims to disrupt the endodontic device market in the US and EU. Our mission is to develop the most advanced solution for this very challenging dental procedure with a disruptive cleaning technology and a novel, light-activated filler, thus helping people to keep their natural teeth longer. We are looking for a Q&R manager to run our QMS and to ensure compliance with the regulatory requirements.
Job description
As a quality manager, your ambition is to assure that Lumendo’s products are safe & effective for the patient. To do so, you implement effective quality measures throughout the product lifecycle, from development to production, supply chain, and post-market activities. You are responsible to maintain, strengthen and extend the existing quality management system across all functions and systems and coordinate the interaction with our notified body and the FDA. You develop and maintain the technical files of our products and support the development team in creating the design history files.
As a regulatory manager, you are responsible for obtaining the marketing approvals of our products, which includes submission of the dossiers to and interaction with the authorities. Following market approval, you ensure compliance of our products and processes with regulatory requirements. The target markets for our launch are the US in 2024 and the EU in 2025, followed by further expansion to the Middle East and Asia in 2026 and beyond.
As a Q&R manager, you enjoy being the backbone of the company. You facilitate the company's mission to develop and launch the products, coach and train the team in your area of expertise and foster efficient solution-finding for the challenges ahead. You are comfortable working in a multinational team of engineers, dentists, clinical, and marketing specialists.
Tasks
- Maintain, improve, and verify the effectiveness of Lumendo’s QMS according to ISO 13485 & 21 CFR 820.
- Obtain market approvals and ensure regulatory compliance.
- Handle non-conformities, change control, CAPAs, complaint, feedback, and vigilance.
- Conduct management reviews, audits, and trainings.
- Manage interaction with our notified body, the FDA, and other authorities.
- Review design and manufacturing records and ensure compliance with the norms and regulations.
- Manage the technical files of Lumendo’s products under EU MDR and FDA requirements.
- Assist design review, risks management, usability engineering, and clinical evaluation activities and provide your feedback from the quality perspective.
- Support the management in developing and growing the company. Coach and train the team members in your area of expertise.
**Requirements**:
- Background in science or engineering and at least 5 years of work experience in the medical device industry in a quality or Q&R position and ready for stepping up in leadership responsibilities.
- Thorough experience in setting up and maintaining a quality management system for medical devices is a must. Experience in regulatory affairs (FDA and MDR) is a plus.
- Expert knowledge and hands-on experience of the applicable norms and regulations: EU MDR, ISO 13485, 21 CFR 820, ISO 14971, ISO 10993, IEC 62366.
- Ability to create documentation efficiently. Excellent mastery of the English language.
- Flexible mindset and quick grasp. Autonomous, hands-on, solution-oriented working style.
- Highly motivated, outgoing, entrepreneurial, and responsible personality.
**Benefits**:
- A work that matters and can help improve people’s life.
- An opportunity to shape a growing MedTech startup and support the first market launch and growth phase.
- A startup environment, giving you high responsibility and room for personal development and learning.
- A young, entrepreneurial, international, and enthusiastic team of 10 people with a common goal.
- Participation in the company’s success through an attractive Employee Stock Ownership Plan (ESOP).
- Flexible working hours, including the possibility of home office. 25 days of holidays.
- Well-located office close to Stettbach station.
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