Quality & Regulatory manager for MedTech startup

Want to have an impact on the life of hundreds of millions of patients Join us at Odne!

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. Since the role will require primarily hands‑on tasks and teamwork we are open to a junior candidate with limited experience.

As a quality manager your ambition is to assure that Odnes 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 for maintaining strengthening and extending the existing quality management system across all functions and systems and 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. Odnes 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 while maintaining a hands‑on and supportive working style. You facilitate the companys mission to develop innovative products and foster efficient solution‑finding for the challenges ahead. You are comfortable working in a multinational team of engineers clinical and sales & marketing specialists.

Quality Affairs

• Maintain improve and verify the effectiveness of Odnes QMS according to ISO 13485 & 21 CFR 820.
• 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 and evaluate management reviews trainings and audits (internal & supplier as a lead‑or co‑auditor).
• 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 together with the team and ensure regulatory compliance.
• Review design and manufacturing records and ensure compliance with the norms and regulations.
• Structure the technical files of Odnes 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 Odnes 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 analyses.

• Background in science or engineering and at least basic hands‑on experience in the medical device industry in a quality or Q&R position preferably from a SME/ small company setting.
• Experience in setting up and maintaining a quality management system for medical devices. Experience in regulatory affairs (FDA and MDR) and experience as lead or co‑auditor is a plus.
• Good knowledge and hands‑on experience of the applicable norms and regulations: EU MDR ISOCFR 820 ISO 14971. Knowledge of ISO 10993 IEC 60601 or IEC 62366 or other product‑specific norms is a plus.
• Ability to create documentation correctly…