Requirements: English
Company: WhatJobs
Region: Zrich , Zurich
Direct message the job poster from SciPro
Principal Specialist Consultant at Scipro - Medical Devices & Digital Health across DACH
Scipro seeking an experienced Senior QARA Consultant specializing in Software as a Medical Device (SaMD) for a specialist life sciences consultancy in Switzerland. This role will focus on guiding clients through regulatory challenges and quality management for medical software products, from development through post-market activities.
Key Responsibilities
- Develop regulatory strategies for SaMD, including preparing 510(k), De Novo, CE Marking, and international submissions.
- Implement and maintain QMS processes aligned with standards such as ISO 13485, IEC 62304, and FDA QSR.
- Lead risk management activities according to ISO 14971 and IEC 62304, working with teams to integrate risk, cybersecurity, and validation.
- Oversee technical documentation, clinical evaluations, and post-market surveillance.
- Provide strategic regulatory and quality advice to clients, keeping them informed on regulatory updates and best practices.
Requirements
- Experience: 7+ years in QARA roles within the medical device or SaMD field, including 3+ years in SaMD-focused work.
- Bachelor''s or Master''s in Biomedical Engineering, Regulatory Affairs, Quality Management, or related field.
- Deep understanding of FDA, EU MDR, ISO 13485, IEC 62304, and ISO 14971 standards; familiarity with software lifecycle and cybersecurity as they apply to SaMD.
Scipro is acting on behalf of this company. Please apply now or send your CV to to arrange a confidential conversation.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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