Lausanne
R&D Compliance Expert (Compliance SME)
- 10 July 2026
- 100%
- Permanent position
- French (Intermediate)
- 1000 Lausanne
About the job
As an R&D Compliance Expert (Subject Matter Expert), you will join the R&D team to act as the primary Quality and Compliance representative within the group. You will ensure that the development and modifications of the product portfolio strictly comply with regulatory and quality requirements.
Your responsibilities:
Compliance guarantor: Ensure that design control and quality management system (QMS) requirements are properly applied throughout the product lifecycle.
Regulatory oversight: Provide compliance oversight and guidance for engineering changes, product modifications, and lifecycle management.
Document review: Review and validate design control deliverables (design reviews, risk management files, V&V documentation, change records).
Quality investigations: Support investigations into deviations, non-conformities, complaints, and CAPA, including root cause analysis and effectiveness verification.
Audits & continuous improvement: Collaborate with Regulatory Affairs and Quality to maintain audit readiness while contributing to continuous process improvement.
Training: Provide guidance and training to project teams on regulatory and quality expectations.
Your profile:
Bachelor’s or Master’s degree in engineering, life sciences, quality management, or biomedical engineering.
5 to 10 years of experience in quality assurance, R&D compliance, or product development quality within a regulated industry.
Strong knowledge of design controls, change management, V&V, risk management, and product lifecycle.
Excellent understanding of applicable medical device requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR principles).
Familiarity with CAPA, deviations, non-conformities, and post-market quality processes.
Experience participating in regulatory audits and inspections is highly desirable.
Strong analytical and risk assessment skills with the ability to positively influence cross-functional teams.
Fluent English is essential; French is a significant advantage.
