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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.
  

 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type: Contract 

Alternative Locations: Switzerland : Basel 

Travel Percentage: 0 - 10% 

Requisition ID: 13104