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. /p pThe 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. /p pbPlease note that this role is 100% based at our headquarters in Heerbrugg, St Gallen. /b /p h3What You'll Be Doing: /h3 ul liAct as Deputy Management Representative for the Sophi and LUMed businesses, supporting the effective management of Regulatory Affairs (RA) and Quality Assurance (QA). /li liLead, manage and develop the RA/QA team, fostering a high-performance and quality-focused culture. /li liAct as Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of Regulation (EU) 2017/745. /li liEnsure ongoing regulatory and quality compliance across all relevant markets and jurisdictions, supporting international expansion and new product launches. /li liLead and oversee regulatory submissions, product registrations, approvals and regulatory timelines worldwide. /li liMaintain robust RA/QA systems, records and documentation, ensuring activities are appropriately controlled and traceable. /li liSupport and coordinate inspections and audits by Notified Bodies and National Competent Authorities. /li liOversee vigilance, product investigations, recalls, non-conformances and CAPA processes, ensuring timely and effective corrective and preventive actions. /li liIdentify and elevate regulatory or quality risks, failures and potential compliance issues, providing appropriate recommendations and follow-up. /li liKeep up to date with evolving regulatory and quality requirements and ensure relevant changes are communicated and embedded across the business. /li liWork collaboratively with Commercial, Marketing and other internal teams to support business growth and market expansion. /li liCollaborate with the wider Rayner Surgical Group Regulatory and Quality network to share knowledge and harmonise best practice. /li liSupport the development and delivery of appropriate RA/QA training across the organisation. /li liManage the RA/QA department budget and resources effectively, ensuring priorities and project timelines are achievable. /li /ul pPlease note that the above list is not exhaustive. A full job description will be shared with shortlisted candidates prior to interview. /p h3What Experience Skills You Will Need: /h3 ul liExperience in management of complex Medical Device regulatory projects and RA/QA activities /li liGreater than 5 years regulatory affairs and international registration submissions experience, including the hosting of audits and inspections /li liSolid 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 /li liExperience with, and knowledge of, other ROW regulatory agencies /li liExperience in Quality Management in a Regulated Environment /li liManagement/Leadership of multidisciplinary teams /li liFluency in German, professional business proficiency in English /li liExperience as a budget holder (desirable) /li /ul h3What We Can Offer You: /h3 ul liComprehensive global benefits package /li liWellbeing allowance /li liAnnual programme of fun events /li liBeing part of an organisation you can be proud to work for changing the lives of millions of people! /li /ul /p #J-18808-Ljbffr