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- Aufgaben: Guide clients through regulatory challenges for medical software products.
- Arbeitgeber: Join a specialist life sciences consultancy in Switzerland.
- Mitarbeitervorteile: Enjoy a full-time role with opportunities for professional growth.
- Warum dieser Job: Make a real impact in the medical device industry while working on innovative projects.
- Gewünschte Qualifikationen: 7+ years in QARA roles, with a focus on SaMD and relevant degrees.
- Andere Informationen: Work with cutting-edge technology and stay updated on regulatory best practices.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
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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Senior SaMD QARA Consultant Arbeitgeber: SciPro
Kontaktperson:
SciPro HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior SaMD QARA Consultant
✨Tip Number 1
Network with professionals in the medical device and SaMD fields. Attend industry conferences, webinars, or local meetups to connect with others who may have insights or opportunities related to the Senior QARA Consultant role.
✨Tip Number 2
Stay updated on the latest regulatory changes and best practices in SaMD. Follow relevant publications, join online forums, and participate in discussions to demonstrate your knowledge and passion for the field during conversations with potential employers.
✨Tip Number 3
Prepare to discuss specific examples of your experience with regulatory strategies and quality management systems. Be ready to share how you've successfully navigated challenges in previous roles, particularly those related to ISO standards and FDA regulations.
✨Tip Number 4
Consider reaching out directly to the job poster or other contacts at Scipro. A personalized message expressing your interest in the role and highlighting your relevant experience can make a strong impression and set you apart from other candidates.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior SaMD QARA Consultant
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and requirements. Highlight your relevant experience in QARA roles, especially in Software as a Medical Device (SaMD).
Tailor Your CV: Customize your CV to emphasize your 7+ years of experience in QARA roles, focusing on your SaMD expertise. Include specific examples of regulatory strategies you've developed and QMS processes you've implemented.
Craft a Compelling Cover Letter: Write a cover letter that showcases your deep understanding of FDA, EU MDR, ISO standards, and your familiarity with software lifecycle and cybersecurity. Explain how your background aligns with the company's needs and how you can add value.
Highlight Relevant Projects: In your application, mention specific projects where you led risk management activities or provided strategic regulatory advice. This will demonstrate your hands-on experience and ability to guide clients through regulatory challenges.
Wie du dich auf ein Vorstellungsgespräch bei SciPro vorbereitest
✨Showcase Your Regulatory Knowledge
Make sure to highlight your experience with regulatory strategies for SaMD, including familiarity with 510(k), De Novo, and CE Marking processes. Be prepared to discuss specific examples where you've successfully navigated these challenges.
✨Demonstrate Quality Management System Expertise
Discuss your experience in implementing and maintaining QMS processes aligned with ISO 13485 and IEC 62304. Share insights on how you have integrated these standards into your previous roles and the impact it had on product quality.
✨Emphasize Risk Management Skills
Prepare to talk about your experience leading risk management activities according to ISO 14971. Provide examples of how you've worked with teams to address risk, cybersecurity, and validation in medical software products.
✨Stay Updated on Regulatory Changes
Show that you are proactive in keeping up with regulatory updates and best practices. Discuss any recent changes in the FDA or EU MDR that you find significant and how they could impact clients in the SaMD space.
