Head of RAQA Sophi

Rayner Surgical Group; Lavamünd; Vor Ort; EUR 191.000 - 297.000; Vollzeit

Benefits dieser Stelle

Comprehensive global benefits package

Wellbeing allowance

Annual programme of fun events

Zusammenfassung

Rayner Surgical Group is seeking Head of Regulatory Affairs and Quality Assurance based at our Heerbrugg, St. Gallen headquarters. You will lead RA/QA for the Sophi and LUMed brands, reporting to the Director of Regulatory Affairs and collaborating across Regulatory, Quality and business teams.

You will act as PRRC, oversee global submissions, inspections, CAPA, training, and budget management while driving a high-performance culture and supporting international expansion.

Qualifikationen

• Experience managing complex medical device regulatory projects and RA/QA activities.
• 5+ years in regulatory affairs and international submissions, including audits.
• Solid knowledge of cGMP, FDA 21 CFR Part 820, EU MDR 2017/745, and ISO 13485.
• Experience with ROW regulatory agencies and regulatory inspections.
• Budget ownership and leadership of multidisciplinary teams.

Aufgaben

• Act as Deputy Management Representative for RA/QA for Sophi and LUMed.
• Lead, manage, and develop the RA/QA team with a high-performance culture.
• Serve as PRRC under EU MDR 2017/745.
• Ensure regulatory and quality compliance across markets and support expansion.
• Lead regulatory submissions, registrations, approvals and timelines worldwide.
• Maintain RA/QA systems and documentation with traceability.
• Coordinate inspections and audits by Notified Bodies and Authorities.
• Oversee vigilance, investigations, recalls, non-conformances and CAPA.
• Identify regulatory/quality risks and provide remediation actions.
• Stay updated on regulatory changes and disseminate across the business.
• Collaborate with Commercial, Marketing and other teams to support growth.
• Share best practices with Rayner Surgical Group Regulatory and Quality network.
• Develop and deliver RA/QA training; manage department budget and resources.

Kenntnisse

Regulatory leadership

Medical device regulatory

Quality systems

Budget management

Team management

German language

English language

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 escalation 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 ensuring 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:

• Comprehensive global benefits package


• Wellbeing allowance


• Annual programme of fun events


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