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
Your role
The Regulatory Affairs Manager is responsible for all EU/US/CA regulatory affairs deliverables for product development, compliance projects and management of lifecycle deliverables and activities linked to processes and compliance. The RA Manager ensures timely execution of regulatory strategies to support launch activities and compliance status for maintenance projects and activities.
Your main responsibilities are:
- Ownership of systems and procedures required for compliance including ensuring consistency in classifications, strategies and documentation
- Establishing and maintaining processes allowing compliant and timely submissions for new launch projects and compliance projects
- Process establishment and SOP creation and maintenance
- Provide regulatory guidance in projects related to compliance
- Ensuring timely maintenance activities for all registrations, listings, schedules, sampling plans, submissions, technical files and article information
- Ensuring Nobel Biocare is compliant and audit ready
- Monitoring of upcoming legislative requirements
- Contact authorities in regards to product and establishment registrations and licences and other similar activities
- Development and execution of regulatory strategies for development projects, product change projects, compliance projects and lifecycle management activities
- Creation, review and/or approval of documents of the design control process
- Providing regulatory input to cross-functional project teams including global impact assessments
- Ownership process local EU registers, databases
- Review and approval of product related labeling, IFUs and marketing material and associated claims
- Assessment, approval and regulatory implementation of change requests
Are you a service-oriented personality combined with strong analytical and problem-solving skills and the willingness to be part of an international, cross-functional team?
- Bachelor degree or equiv. Diploma in Technology or Science
- Min. 3 years’ experience in regulatory affairs within medical device industry
- Experience in preparation, submission of US regulatory files (510(k)s, PMAs) and interface with FDA during review process
- In depth knowledge of EU, US and CA medical device regulations
- In depth knowledge of design control process requirements and requirements for technical documentation for medical devices
- Excellent communication skills verbally and written, with multicultural sensitivity
- Fluency in English is required (German is an advantage)