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 1 to 3 years 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: Full Time

Alternative Locations: Switzerland : Basel

Travel Percentage: 0 - 10%

Requisition ID: 13005

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