Regulatory & Quality Assurance Specialist for Medical Device Innovation
vor 1 Monat
We're seeking a seasoned Quality & Regulatory Manager to oversee our Quality Management System (QMS) and ensure compliance with regulatory requirements. As a key member of our team, you'll be responsible for maintaining, improving, and verifying the effectiveness of our QMS according to ISO 13485 & 21 CFR 820.
As a Management Representative and Person Responsible for Regulatory Compliance (PRRC), you'll handle non-conformities, change control, CAPAs, complaints, feedback, and vigilance and medical device reporting activities. You'll also plan, conduct, monitor, and evaluate management reviews, trainings, and audits (internal & supplier) and manage interaction with our notified body, the FDA, and other authorities.
You'll participate in qualification and validation activities (e.g., process validation, computer software validation, etc.) and manage equipment and supplier qualifications, including setting up quality agreements. Your role will also involve releasing raw materials and products and maintaining 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 ComplianceYou'll obtain market approvals and ensure regulatory compliance, reviewing design and manufacturing records and ensuring compliance with norms and regulations. You'll manage the technical files of Odne's products under EU MDR and FDA requirements, reviewing and approving product information (product specifications, bill of materials, labels, IFU, UDI data), risk management files, usability files, and clinical evaluation files. You'll oversee Odne's post-market activities and documentation, assisting design review, risk management, usability engineering, and clinical evaluation activities, and provide your feedback from the quality perspective. Additionally, you'll coach and train the team members in your area of expertise, monitoring laws and applicable standards, and other regulatory updates (harmonized standards, MDCG guidances, etc.), performing gap analysis.
RequirementsWe're looking for a background in science or engineering with at least 5 years of work experience in the medical device industry in a quality or Q&R position, ready for stepping up in leadership responsibilities. You should have thorough experience in setting up and maintaining a quality management system for medical devices, with experience in regulatory affairs (FDA and MDR) being 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 is also required. Ability to create documentation efficiently and excellent mastery of the English language are essential. High IT proficiency, experience with MS SharePoint, MS Access, SQL, and/or PowerApps, is a plus. We're looking for a flexible mindset and quick grasp, with an autonomous, hands-on, solution-oriented working style. A highly motivated, outgoing, entrepreneurial, and responsible personality is also required. Finally, we offer a work that matters, an opportunity to shape a growing MedTech startup, and a startup environment giving you high responsibility and room for personal development and learning. We also offer 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, and a well-located office close to the Stettbach station and the highway. We look forward to receiving your application.
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