Head of RA/QA - Medical Devices Leadership

Rayner Surgical Group; Sankt Gallen; On-site; CHF 150,000 - 210,000; Full time

Benefits offered by this job

Global benefits

Wellbeing allowance

Annual events programme

Proud to work here

Job summary

Rayner Surgical Group in Switzerland is seeking a Head of Regulatory Affairs and Quality Assurance to lead the RA/QA function for the Sophi and LUMed businesses. The role reports to the Director of Regulatory Affairs and collaborates with groups across the Rayner Group.

Based 100% at the Heerbrugg HQ in St. Gallen, you will manage the RA/QA team, ensure regulatory compliance, drive submissions and oversee audits, CAPA and risk management across markets.

Qualifications

• Experience in managing complex medical device regulatory projects and RA/QA activities.
• 5+ years of regulatory affairs and international registration submissions experience, including hosting audits and inspections.

Responsibilities

• Act as Deputy Management Representative for the Sophi and LUMed businesses, supporting the effective management of Regulatory Affairs (RA) and Quality Assurance (QA).
• Lead, manage and develop the RA/QA team, fostering a high-performance and quality-focused culture.
• Act as Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of Regulation (EU) 2017/745.
• Ensure ongoing regulatory and quality compliance across all relevant markets and jurisdictions, supporting international expansion and new product launches.
• Lead and oversee regulatory submissions, product registrations, approvals and regulatory timelines worldwide.
• Maintain robust RA/QA systems, records and documentation, ensuring activities are appropriately controlled and traceable.
• Support and coordinate inspections and audits by Notified Bodies and National Competent Authorities.
• Oversee vigilance, product investigations, recalls, non-conformances and CAPA processes, ensuring timely and effective corrective and preventive actions.
• Identify and elevate regulatory or quality risks, failures and potential compliance issues, providing appropriate recommendations and follow-up.
• Keep up to date with evolving regulatory and quality requirements and ensure relevant changes are communicated and embedded across the business.
• Work collaboratively with Commercial, Marketing and other internal teams to support business growth and market expansion.
• Collaborate with the wider Rayner Surgical Group Regulatory and Quality network to share knowledge and harmonise best practice.
• Support the development and delivery of appropriate RA/QA training across the organisation.
• Manage the RA/QA department budget and resources effectively, ensuring priorities and project timelines are achievable.

Skills

Regulatory leadership

RA/QA management

Regulatory submissions

Budget management

Compliance knowledge

Job description

Rayner Surgical Group in Switzerland is seeking a Head of Regulatory Affairs and Quality Assurance to lead the RA/QA function for the Sophi and LUMed businesses. The role reports to the Director of Regulatory Affairs and collaborates with groups across the Rayner Group.

Based 100% at the Heerbrugg HQ in St. Gallen, you will manage the RA/QA team, ensure regulatory compliance, drive submissions and oversee audits, CAPA and risk management across markets.