Regulatory Affairs & Compliance Manager - Dental Implant System - 12 Months (f/m/d)
Straumann Group
- Basel
- Freiberuflich
- Vollzeit
- Support product development process and ensure compliance of deliverables
- Compile the Regulatory Strategy
- Support/Review/Approve labeling (Labels, IFU’s, relevant Marketing Material) from a compliance and regulatory point of view
- Ensure that the technical documentation supporting the CE mark complies with MDR EU 2017/745
- Create and maintain Technical Files/ Design Dossiers for EU for MDR EU 2017/745
- Ensure compliance with other RA relevant matters of MDR EU 2017/745 (e.g. EUDAMED, UDI, local registration CE+, information to distributors)
- Perform conformity assessment according to MDR EU 2017/745
- Ensure compliance with relevant US & Canadian regulations
- Create & submit submission files for US & Canada
- Support the International Regulatory Affairs-Team (review of Core dossier & support in registration process)
- Support during Audits
- Interaction with authorities, notified bodies and any other approving bodies that will be relevant
- Support/assess change requests in accordance with MDR EU 2017/745, US & Canadian regulations
- Assessment of potential risks and the classification of the medical device in accordance with MDR EU 2017/745, US & Canadian regulations
- Communication of new regulatory requirements and support in implementing these.
Required
- Technical or scientific graduate degree (FH/Uni/ETH) and/or minimum 4 years of professional experience in Medical Device Regulatory Affairs and/or Quality Management
- Fluent (written and spoken) in English
- Detailed knowledge about the standards and norms for Medical Products such as ISO13485, ISO 14971, EU 2017/745
- Energetic, straight forward and performance-driven professional with strong execution abilities and customer focus
- Strong analytical skills and result-oriented
- Effective and convincing communication, both verbally and in writing
- Experience and appropriate technical skills including knowledge of regulatory and quality strategies to improve compliance profile.
- Experience in the functions of Medical Device regulatory affairs and compliance: competent authority/notified body relations, compliance measures, inspections, complaints, engineering, audit processing, regulatory submissions,…
- Experience and technical knowledge of product design, manufacturing, process for lifecycle management.