Global Head of Regulatory Affairs & QA

Rayner; Sankt Gallen; On-site; CHF 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive global benefits package

Wellbeing allowance

Annual programme of fun events

Job summary

Rayner seeks a Head of RAQA based at our Heerbrugg, St. Gallen headquarters to lead Regulatory Affairs and Quality Assurance for Sophi and LUMed. You will report to the Director of Regulatory Affairs and collaborate with global teams across the Rayner Group.

You will act as Deputy Management Representative, manage the RA/QA team, ensure compliance, lead submissions, and oversee audits, CAPAs and quality systems for international markets.

Qualifications

• Experience in management of complex Medical Device regulatory projects and RA/QA activities
• 5+ years regulatory affairs and international registration submissions experience, including hosting audits and inspections
• Solid knowledge of cGMP, FDA 21 CFR Part 820, Regulation (EU) 2017/745 and ISO 13485 (Medical Device QMS)

Responsibilities

• Act as Deputy Management Representative for the Sophi and LUMed businesses, supporting RA/QA
• Lead and develop the RA/QA team, fostering a high-performance, quality-focused culture
• Act as PRRC in accordance with EU 2017/745 Article 15
• Ensure regulatory and quality compliance across markets and support international expansion
• Lead regulatory submissions, product registrations, approvals and timelines worldwide
• Maintain RA/QA systems, records and documentation with traceability
• Coordinate inspections and audits by Notified Bodies and National Competent Authorities
• Oversee vigilance, investigations, recalls, non-conformances and CAPA processes
• Identify regulatory/quality risks and recommend actions
• Stay updated on evolving regulatory requirements and communicate changes
• Collaborate with Commercial/Marketing and internal teams to support growth
• Share knowledge and harmonise best practice within Rayner Surgical Group network
• Develop and deliver RA/QA training across the organisation
• Manage RA/QA department budget and resources to meet priorities and timelines

Skills

Regulatory leadership

RA/QA management

Audit coordination

Regulatory strategy

Budget management

German fluent

English business proficiency

Job description

Rayner seeks a Head of RAQA based at our Heerbrugg, St. Gallen headquarters to lead Regulatory Affairs and Quality Assurance for Sophi and LUMed. You will report to the Director of Regulatory Affairs and collaborate with global teams across the Rayner Group.

You will act as Deputy Management Representative, manage the RA/QA team, ensure compliance, lead submissions, and oversee audits, CAPAs and quality systems for international markets.