Regulatory Affairs Specialist(m/w/x)

As a Regulatory Affairs Specialist, you will navigate the complexities of regulatory submissions and compliance, ensuring that all documentation is meticulously prepared and that the company stays ahead of regulatory changes. This role involves collaborating with various teams to recommend improvements and strategies for successful approvals.

Anforderungen

• •Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
• •2-5 years of medical device regulatory experience tied to Swissmedic submissions and processes
• •Strong knowledge of Swiss Medical Device Ordinance (MedDO/MepV)
• •Understanding of EU MDR compliance
• •Experience with conformity assessment procedures under Swiss law
• •Proficiency in German, English, and French
• •Experience in ISO 13485 Quality Management Systems
• •Risk management experience (ISO 14971, EN 14971)
• •Strong background in understanding of Swiss device classification system
• •Clinical evaluation and post-market surveillance knowledge
• •Strong knowledge of Swiss Authorized Representative requirements
• •Experience with Swissmedic registration processes
• •Technical documentation preparation
• •Interaction with Notified Body for EU conformity assessment
• •Import/distribution licensing procedures experience
• •Field Safety Corrective Actions (FSCA) support experience
• •Expertise in hosting or supporting regulatory audits