Senior Quality & Regulatory Affairs Leader

Geneva Com; Genf; Hybrid; CHF 150,000 - 190,000; Full time

Job summary

Geneva Com seeks a Senior Manager of Quality & Regulatory Affairs to ensure regulatory and quality compliance for FIND-sponsored human subject research. The role maintains the quality management system and oversees regulatory activities within the organization.

The candidate will engage with internal and external partners, lead audits, and drive CAPA-driven quality improvements across geographies, with strong English and French communication skills.

Qualifications

• Graduate or post graduate degree in an appropriate scientific discipline.
• Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM).

Responsibilities

• Leads the revision of the Clinical QMS with other FIND departments and research teams.
• Identifies QM systemic gaps and coordinates remediation with stakeholders.
• Provides expertise in ISO14155 / ISO20916 / ISO13485 to ensure study quality.
• Provides QA oversight of partners, vendors, and investigator sites for compliance.
• Oversees regulatory compliance for all products in portfolio (ISO 13485).
• Handles submissions, maintenance, and renewals of product approvals in various regions.
• Monitors regulatory requirements across target geographies and updates accordingly.
• Leads audits of partners, sites, and vendors and facilitates CAPA implementation.
• Advises on internal audits and leads some as required.
• Maintains understanding of global standards, regulations, and regulatory bodies.

Skills

Regulatory Affairs

Quality Management

QA Audits

GCP/ISO

Education

Graduate degree in science

Tools

MS Office

Job description

Geneva Com seeks a Senior Manager of Quality & Regulatory Affairs to ensure regulatory and quality compliance for FIND-sponsored human subject research. The role maintains the quality management system and oversees regulatory activities within the organization.

The candidate will engage with internal and external partners, lead audits, and drive CAPA-driven quality improvements across geographies, with strong English and French communication skills.