Regulatory Affairs & Compliance Manager - Dental Implant System
Straumann
Basel, Switzerland
Job Purpose
Be a member of product development project-teams from the initiation phase, ensure implementation of quality and Regulatory Affairs requirements for Europe, US & Canada, perform product registration in EU, US & Canada.
Main Tasks and Responsibilities
- 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.
Profile
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.
Expected
- 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.
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