RnD Compliance SME

K-Recruiting GmbH; Schweiz; Vor Ort; EUR 97.317 - 140.570; Vollzeit

Zusammenfassung

K-Recruiting GmbH in the Lausanne-Genève area seeks an R&D Compliance SME (M/W/D) to ensure regulatory and quality standards across disposable kits in biopharma and medical device development.

You will act as the quality representative for design controls, risk management, and lifecycle processes, collaborating with multidisciplinary teams to support investigations and continuous improvement.

Start Sept 2026, 4 months with possible extension, full-time onsite.

Qualifikationen

• Degree in engineering, life sciences, or a related technical field.
• Several years of experience in quality, compliance, or product development within a regulated environment.
• Strong understanding of design controls, validation, risk management, and lifecycle processes.
• Knowledge of ISO 13485, FDA regulations, EU MDR is beneficial.

Aufgaben

• Serve as the main point of contact for quality and compliance topics within the disposable kits R&D team.
• Ensure proper application of design control, risk management, and quality system requirements across product lifecycle activities.
• Review and support documentation such as design reviews, validation plans, and change control records.
• Provide guidance on product modifications, engineering changes, and compliance-related assessments.
• Collaborate with cross-functional teams and support investigations (deviations, CAPAs, complaints) while promoting continuous improvement.

Kenntnisse

Quality management

Regulatory compliance

Cross-functional collaboration

English language

French language

Ausbildung

Engineering or life sciences degree

Jobbeschreibung

R&D Compliance SME (M/W/D)

This role is a Compliance Subject Matter Expert within an R&D team focused on disposable kits used in biopharma and medical device applications. The position sits in a multidisciplinary environment supporting product development and lifecycle management. Acting as the key quality representative, the role ensures that products and changes meet regulatory and quality standards.

Tasks

• Serve as the main point of contact for quality and compliance topics within the disposable kits R&D team.
• Ensure proper application of design control, risk management, and quality system requirements across product lifecycle activities.
• Review and support documentation such as design reviews, validation plans, and change control records.
• Provide guidance on product modifications, engineering changes, and compliance-related assessments.
• Collaborate with cross-functional teams and support investigations (deviations, CAPAs, complaints) while promoting continuous improvement.

Qualifications

• Degree in engineering, life sciences, or a related technical field.
• Several years of experience in quality, compliance, or product development within a regulated environment.
• Strong understanding of design controls, validation, risk management, and lifecycle processes.
• Knowledge of relevant regulations and standards (e.g., ISO 13485, FDA regulations, EU MDR).
• Good communication skills, with the ability to work cross-functionally; English required, French is a plus.

Conditions

• Start: Sept 2026
• Duration: 4 months + extension
• Workload: Full-time
• Location: Onsite Lausanne-Genève