Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single tooth to fully edentulous indications. We offer dental implant systems, high-precision individualized prosthetics and CAD/CAM systems, diagnostics, treatment planning, guided surgery solutions and biomaterials. We support customers throughout their professional and practice development. Nobel Biocare Headquarters is based in Zurich-Airport, Switzerland, and we have around 34 direct sales organizations worldwide. Nobel Biocare is a member of the Envista Cooperation.
To strengthen our Regulatory Affairs Team in Zurich-Kloten we are looking for a
The Regulatory Affairs Specialist supports regulatory affairs activities for design control, compliance projects and lifecycle maintenance for the Nobel Biocare portfolio, with a focus on IFU, labeling, regenerative products and UDI.
In this role you will be accountable for delivery of compliant and accurate submission or maintenance of data in international UDI databases. The Regulatory Affairs Specialist must, with high attention to detail, be able to collect and maintain regulatory data for international medical device databases. As main contributor to these databases, the Regulatory Affairs Specialist must understand sources of and connections in between datasets – this mandates knowledge of the IT systems and databases used to store and process the data.
UDI and Regeneratives
- Maintain UDI processes (e.g. GUDID) and implement additional countries UDI processes (e.g. EUDAMED), incl. monitoring of legislative UDI and medical device database requirements for assigned region
- Ensure timely and accurate UDI submissions for new launch projects
- Provide regulatory input in UDI and RA data governance projects, including testing of new IT, solutions under guidance and supervision
- Support RA processes related to 3rd party regeneratives products, including products for CE, US and CA.
Label and IFU
- Contribute to regulatory knowledge on global labeling and IFU (including eIFU) regulations
- Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes
- Provide input to development and execution of regulatory strategies.
- Support the development and provision of regulatory guidance to project teams in terms of premarket requirements and related submission to support optimal timelines and required compliance levels
- Create, review and maintain technical files under supervision.
- Contribute to review and approval of product related labeling and marketing material and associated claims.
- Contribute to assessment, approval and regulatory implementation of change requests under guidance and supervision.
- Support of internal and external audits in the audit prepration and audit backoffice
- Support the creation and maintenance of regulatory procedures and templates under guidance.
- Provide internal trainings on relevant regulatory procedures and requirements.
- Support standard committee work including creation of gap analyses.
- Monitor closely guidelines, regulations, changes in the marketplace and regulator positions for the assigned markets.
KNOWLEDGE, SKILLS & EXPERIENCE
Critical Knowledge and Qualifications:
- A minimum of a Bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage. A degree focused in technology or science is preferred.
- Knowledge of EU, US and CA medical device regulations. Further markets is an advantage.
- Knowledge of requirements for technical documentation of medical devices or similar devices
- Knowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485
Critical Skills/technical know-how:
- Fluency in English a must. German or further languages is an advantage.
- Experience in SAP including data handling and Office based programs, especially Excel
- Minimum 2 years experience in regulatory affairs within medical device industry.
This Job is also suitable for persons with disabilities; attendance required – disabled-accessible building.