Head of RAQA Sophi

Rayner; Sankt Gallen; Vor Ort; CHF 180.000 - 250.000; Vollzeit

Benefits dieser Stelle

Annual programme of fun events

Zusammenfassung

Rayner seeks a Head of Regulatory Affairs & Quality Assurance to lead the RA/QA functions for the Sophi and LUMed businesses. Based at the Heerbrugg headquarters, you will report to the Director of Regulatory Affairs and collaborate with Regulatory, Quality and business teams across the Group.

You will act as PRRC under EU MDR, manage submissions and audits, drive continuous improvement, and ensure compliance across markets while supporting international expansion and new product launches.

Qualifikationen

• Experience in complex Medical Device regulatory projects and RA/QA activities.
• >5 years regulatory affairs and international registration submissions experience, including hosting audits/inspections.
• Solid knowledge of cGMP, FDA 21 CFR Part 820, Regulation (EU) 2017/745 and ISO 13485/13845.
• Experience with other ROW regulatory agencies.
• Budget management experience is desirable.

Aufgaben

• Lead RA/QA team and develop a high-performance culture.
• Act as PRRC under Regulation (EU) 2017/745.
• Oversee regulatory submissions, product registrations and timelines worldwide.
• Maintain RA/QA systems, records and documentation.
• Coordinate inspections/audits by Notified Bodies and National Competent Authorities.
• Manage vigilance, investigations, CAPA and recalls as needed.
• Collaborate with cross-functional teams to support business growth and market expansion.

Kenntnisse

Regulatory leadership

RA/QA management

PRRC expertise

Audits & inspections

Budget management

Jobbeschreibung

The Head of RAQA sits within This AG, the Swiss developer and manufacturer of the Sophi phacoemulsification system and part of the Rayner Group.

The role will lead Regulatory Affairs and Quality Assurance activities for the Sophi and LUMed businesses and will report to Rayner’s Director of Regulatory Affairs, while working closely with Regulatory, Quality and business teams across the wider Group.

Please note that this role is 100% based at our headquarters in Heerbrugg, St Gallen.

What You'll Be Doing:

• 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.

Please note that the above list is not exhaustive. A full job description will be shared with shortlisted candidates prior to interview.

What Experience & Skills You Will Need:

• Experience in management of complex Medical Device regulatory projects and RA/QA activities
• Greater than 5 years regulatory affairs and international registration submissions experience, including the hosting of audits and inspections
• Solid working knowledge of cGMP, FDA 21 CFR Part 820 Quality Systems Regulation and related regulations, Regulation (EU) 2017/745 and ISO 13845 Medical Device Quality Management Systems
• Experience with, and knowledge of, other ROW regulatory agencies
• Experience in Quality Management in a Regulated Environment
• Management/Leadership of multidisciplinary teams
• Fluency in German, professional business proficiency in English
• Experience as a budget holder (desirable)

What We Can Offer You:

• Annual programme of fun events
• Being part of an organisation you can be proud to work for changing the lives of millions of people!