Quality & Regulatory manager for MedTech startup
vor 1 Monat
About us
Odne (formerly 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.
Job description
We are looking for a Q&R manager to run our QMS and to ensure compliance with the regulatory requirements.
As a quality manager, your ambition is to assure that Odne’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 support the development team in creating and maintaining the technical and design history files.
As a regulatory manager, you are responsible for obtaining the marketing approvals for our products. Following market approval, you ensure compliance of our products and processes with regulatory requirements. Odne’s products are currently cleared by the US FDA; the next step being the MDR certification for sale in Europe 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 and foster efficient solution-finding for the challenges ahead. You are comfortable working in a multinational team of engineers, clinical, and sales & marketing specialists.
TasksQuality Management/ Quality Assurance
- Maintain, improve, and verify the effectiveness of Odne’s QMS according to ISO 13485 & 21 CFR 820.
- Act as a Management Representative and Person Responsible for Regulatory Compliance (PRRC).
- Handle, assess, evaluate and analyze non-conformities, change control, CAPAs, complaints, feedback, and vigilance and medical device reporting activities and connect the internal and external stakeholders.
- Plan, conduct, monitor and evaluate management reviews, trainings, and audits (internal & supplier).
- Manage interaction with our notified body, the FDA, and other authorities.
- Participate in qualification and validation activities (e.g. process validation, computer software validation, etc.). Manage equipment and supplier qualifications, including setting up quality agreements.
- Release raw materials and products. Maintain the traceability system of goods stored in our own warehouse and with our third-party logistics provider in the US, as well as the retention sample system
Regulatory Affairs
- Obtain market approvals and ensure regulatory compliance.
- Review design and manufacturing records and ensure compliance with the norms and regulations.
- Manage the technical files of Odne’s products under EU MDR and FDA requirements. Review and approve product information (product specifications, bill of materials, labels, IFU, UDI data), risk management files, usability files, and clinical evaluation files.
- Oversee Odne’s post market activities and documentation. Assist design review, risks management, usability engineering, and clinical evaluation activities and provide your feedback from the quality perspective.
- Coach and train the team members in your area of expertise.
- Monitor laws and applicable standards, and other regulatory updates (harmonized standards, MDCG guidances, etc.), perform gap analysis.
- 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. Knowledge of ISO 10993, IEC 60601, or IEC 62366 or other product-specific norms is a plus.
- Experience as lead auditor in internal audits and supplier audits.
- Ability to create documentation efficiently. Excellent mastery of the English language.
- High IT-proficiency; experience with MS SharePoint, MS Access, SQL, and/or PowerApps is a plus.
- Flexible mindset and quick grasp. Autonomous, hands-on, solution-oriented working style.
- Highly motivated, entrepreneurial, and responsible personality.
- 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 the Stettbach station and the highway.
We look forward to receiving your application. Please include a brief cover letter, explaining your motivation to join our team and why you think your profile matches our requirements. We guarantee an efficient & fair hiring process.
Please note that for legal reasons, we can only consider candidates of CH or EU nationality or candidates with a valid Swiss work permit.
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