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- Aufgaben: Lead the RAQA team for Sophi, ensuring compliance and quality in medical devices.
- Arbeitgeber: Join This AG, part of Rayner Group, innovating in wireless Phaco systems.
- Mitarbeitervorteile: Enjoy private healthcare, wellbeing allowance, and optional family support.
- Warum dieser Job: Be at the forefront of medical innovation while fostering a quality assurance culture.
- Gewünschte Qualifikationen: 5+ years in regulatory affairs with strong knowledge of medical device regulations.
- Andere Informationen: Opportunity to expand into new markets and collaborate with commercial teams.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
We are seeking a Head of RAQA to join This AG – A Rayner Group Company, at our Heerbrugg site in St. Gallen, Switzerland.This is an excellent opportunity to manage our RAQA team dedicated to Sophi, the first wireless Phaco system to offer high flexibility and mobility, providing ease of handling in the operating theatre and increased usability.What You’ll Be DoingAct as Deputy Management Representative in the Sophi and Lumed business to support the effective management of regulatory affairs and quality assurance within Rayner.Immediately highlight any possible risks or failures to meet quality requirements to the Company’s attention; report as required to stakeholders on the performance and results of the RA and QA department, and help identify options to solve the issue(s).Manage, motivate and develop the RA/QA team to achieve high performance.Ensure maintenance of systematic records and comprehensive documentation of all RA and QA activities.Help drive and support a quality assurance culture and reduce the reliance on quality control.Ensure that the Company is properly and adequately aware of and in compliance with relevant and applicable regulatory matters in each of the jurisdictions in which it operates or intends to supply existing, new or updated products.Support expansion into new countries and growing our market share, proactively liaising with the Commercial and Marketing teams.Co-ordinate team resources to ensure achievable project and submission timelines are set and provide regular updates to senior management on progress.What Do You NeedExperience in management of complex Medical Device regulatory projects and QA and QMS activities.More than 5 years of 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, European Medical Device Directives and ISO 13485 Medical Device Quality Management Systems.Experience with, and knowledge of, other ROW regulatory agencies.Experience as a budget holder (desirable).What We Can Offer YouPrivate healthcareWellbeing allowanceA voluntary and additional family allowance #J-18808-Ljbffr
Head of RAQA Sophi Arbeitgeber: Rayner Surgical Group
Kontaktperson:
Rayner Surgical Group HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Head of RAQA Sophi
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks and quality management systems relevant to medical devices, such as ISO 13485 and FDA regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the RAQA field, especially those who have experience with wireless medical devices. Engaging with industry experts can provide insights into current trends and challenges, making you a more informed candidate.
✨Tip Number 3
Prepare to discuss your previous experiences managing teams and projects in regulatory affairs. Highlight specific examples where you successfully navigated complex regulatory challenges or improved quality assurance processes.
✨Tip Number 4
Stay updated on the latest developments in medical device regulations and quality assurance practices. Being knowledgeable about recent changes can set you apart from other candidates and show that you are proactive in your professional development.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Head of RAQA Sophi
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Head of RAQA position. Understand the key responsibilities and required qualifications, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in managing complex Medical Device regulatory projects and QA activities. Be specific about your achievements and how they relate to the requirements listed in the job description.
Showcase Leadership Skills: Since the role involves managing and motivating a team, provide examples of your leadership experience. Discuss how you've developed teams in the past and any successful outcomes that resulted from your management style.
Tailor Your Application: Customize your cover letter to reflect your understanding of the company's mission and values. Mention how your background aligns with their goals, particularly in relation to quality assurance and regulatory compliance.
Wie du dich auf ein Vorstellungsgespräch bei Rayner Surgical Group vorbereitest
✨Showcase Your Regulatory Expertise
Be prepared to discuss your experience with complex medical device regulatory projects. Highlight specific examples where you successfully managed submissions and audits, demonstrating your solid knowledge of cGMP and relevant regulations.
✨Demonstrate Leadership Skills
As a Head of RAQA, you'll need to manage and motivate a team. Share your leadership philosophy and provide examples of how you've developed high-performing teams in the past. This will show that you can inspire and guide your future team effectively.
✨Discuss Risk Management Strategies
Since identifying risks is crucial for this role, be ready to talk about your approach to risk management. Provide examples of how you've highlighted potential issues in previous roles and the steps you took to mitigate them.
✨Align with Company Goals
Research This AG and understand their mission and values. During the interview, express how your experience and vision align with their goals, especially regarding quality assurance culture and market expansion strategies.
