R&D Compliance SME
Listed on 2026-07-20
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Have you ever dreamed of working for a company that puts people at the heart of its DNA?
Are you ready to make a difference?
Are you excited about collaborating and sharing your expertise with leaders in our industry?
YES? SO ARE WE!
GXP CONSULTING Switzerland is a Swiss company made up of a passionate team of life‑science professionals. Since 2014, we have been providing our clients with cutting‑edge expertise and support covering the entire product life cycle.
Join a team where your skills will have a real impact on patients’ lives.
In order to continue to successfully support our clients, we are currently looking for a Compliance SME to support the development and lifecycle management of a strategic product portfolio
, ensuring that product and process changes meet all applicable quality and regulatory requirements.
- Ensure Design Control and Quality Management System requirements are applied throughout the product lifecycle
- Advise project teams on compliance aspects during engineering and product changes
- Contribute to design deliverables, risk management files and V&V documentation
- Lead compliance assessments related to product, process and supplier changes
- Support quality investigations (deviations, non‑conformances, CAPAs)
- Collaborate with Regulatory Affairs, Quality, Manufacturing and R&D teams
- Contribute to continuous improvement of quality and compliance processes
- Master’s degree in sciences or engineering or equivalent in experience.
- 5–10 years of experience in Quality Assurance / R&D Compliance within a regulated industry
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820 and EU MDR requirements
- Fluent English required, French is a strong asset
- Autonomous, analytical mindset, strong cross‑functional communication skills
- Human‑sized company with great colleagues from a large diversity of cultural and professional backgrounds
- We do care about our people, communicate openly and value feedback
- Work as a team where every member is valued and appreciated
- Opportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.
- Continuous learning and development opportunities via internal or external training and workshops
- Competitive salary package in line with industry practice together with exceptional employment benefits
At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!
If you also share the same passion and values, we will be glad to hear from you! Please send us your application.
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