Head of RAQA Sophi

ppThe Head of RAQA sits within This AG, the Swiss developer and manufacturer of the Sophi phacoemulsification system and part of the Rayner Group. /ppThe 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. /ppbPlease note that this role is 100% based at our headquarters in Heerbrugg, St Gallen. /b /ppbWhat You'll Be Doing: /b /pulliAct as Deputy Management Representative for the Sophi and LUMed businesses, supporting the effective management of Regulatory Affairs (RA) and Quality Assurance (QA). /liliLead, manage and develop the RA/QA team, fostering a high-performance and quality-focused culture. /liliAct as Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of Regulation (EU) 2017/745. /liliEnsure ongoing regulatory and quality compliance across all relevant markets and jurisdictions, supporting international expansion and new product launches. /liliLead and oversee regulatory submissions, product registrations, approvals and regulatory timelines worldwide. /liliMaintain robust RA/QA systems, records and documentation, ensuring activities are appropriately controlled and traceable. /liliSupport and coordinate inspections and audits by Notified Bodies and National Competent Authorities. /liliOversee vigilance, product investigations, recalls, non-conformances and CAPA processes, ensuring timely and effective corrective and preventive actions. /liliIdentify and elevate regulatory or quality risks, failures and potential compliance issues, providing appropriate recommendations and follow-up. /liliKeep up to date with evolving regulatory and quality requirements and ensure relevant changes are communicated and embedded across the business. /liliWork collaboratively with Commercial, Marketing and other internal teams to support business growth and market expansion. /liliCollaborate with the wider Rayner Surgical Group Regulatory and Quality network to share knowledge and harmonise best practice. /liliSupport the development and delivery of appropriate RA/QA training across the organisation. /liliManage the RA/QA department budget and resources effectively, ensuring priorities and project timelines are achievable. /li /ulpPlease note that the above list is not exhaustive. A full job description will be shared with shortlisted candidates prior to interview. /ppbWhat Experience Skills You Will Need: /b /pulliExperience in management of complex Medical Device regulatory projects and RA/QA activities /liliGreater than 5 years regulatory affairs and international registration submissions experience, including the hosting of audits and inspections /liliSolid 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 /liliExperience with, and knowledge of, other ROW regulatory agencies /liliExperience in Quality Management in a Regulated Environment /liliManagement/Leadership of multidisciplinary teams /liliFluency in German, professional business proficiency in English /liliExperience as a budget holder (desirable) /li /ulpbWhat We Can Offer You: /b /pulliAnnual programme of fun events /liliBeing part of an organisation you can be proud to work for changing the lives of millions of people! /li /ul /p #J-18808-Ljbffr