Global Head of Regulatory Affairs & Quality Assurance

Rayner; Sankt Gallen; On-site; CHF 190,000 - 240,000; Full time

Benefits offered by this job

Annual events

Proud to work for a life-changing org

Job summary

Rayner is seeking a Head of Regulatory Affairs and Quality Assurance to lead the RA/QA functions for the Sophi and LUMed businesses. The role reports to the Director of Regulatory Affairs and collaborates with global teams, reporting closely across the Rayner Group.

The position is 100% based at the headquarters in Heerbrugg, St Gallen, Switzerland, with responsibilities spanning regulatory submissions, audits, and continuous compliance.

Qualifications

• Experience managing complex medical device regulatory projects and RA/QA activities.
• 5+ years regulatory affairs and international submissions experience, incl. audits/inspections.
• Knowledge of cGMP, FDA 21 CFR Part 820, EU Regulation 2017/745, ISO 13485.
• Experience with ROW regulatory agencies.
• Quality management in a regulated environment.
• Leadership of multidisciplinary teams.
• Fluency in German and professional English.
• Budget-holding experience (desirable).

Responsibilities

• Lead Regulatory Affairs and Quality Assurance for the Sophi and LUMed businesses.
• Act as Deputy Management Representative for RA/QA.
• Oversee regulatory submissions, product registrations, and timelines worldwide.
• Maintain robust RA/QA systems and documentation.
• Coordinate inspections and audits by Notified Bodies and authorities.
• Manage CAPA, investigations, recalls, and risk escalation.
• Ensure compliance across markets and support international expansion.
• Collaborate with commercial and other teams to drive growth.

Skills

Regulatory leadership

Regulatory affairs

Quality management

Budget management

German language

English proficiency

Cross-functional leadership

Job description

Rayner is seeking a Head of Regulatory Affairs and Quality Assurance to lead the RA/QA functions for the Sophi and LUMed businesses. The role reports to the Director of Regulatory Affairs and collaborates with global teams, reporting closely across the Rayner Group.

The position is 100% based at the headquarters in Heerbrugg, St Gallen, Switzerland, with responsibilities spanning regulatory submissions, audits, and continuous compliance.