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- Tasks: Lead regulatory compliance and quality management for medical devices in the UK and Ireland.
- Company: Join Intuitive Surgical, a leader in innovative medical technology.
- Benefits: Enjoy flexible working options and a collaborative team environment.
- Why this job: Make a real impact in healthcare while working with top professionals in the field.
- Qualifications: Experience in regulatory affairs and quality systems is essential.
- Other info: Opportunity to travel up to 20% and engage with key industry stakeholders.
The predicted salary is between 60000 - 84000 £ per year.
Job Description Primary Function of Position: Act as a representative of Intuitive Surgical Ltd (UK Responsible Person), importer and distributor under the UK medical device regulations. Management of regulatory operations, post-market surveillance, QMS, liaison with Corporate & global RAQA teams, advocacy with government bodies and manufacturer associations across assigned markets (Especially UK and Ireland). Ensure proper liaison with sales, marketing and service teams as well as all other enabling functions. Roles and Responsibilities: Regulatory Compliance & Quality System Fulfill the role of UK Responsible Person contact and site management representative Responsible for ensuring compliance of the quality system activities (Nonconformance management, audit/inspection, economic operator obligations, post market surveillance) in the target markets Partner with domestic and international teams to develop and execute quality management system strategies in accordance with corporate policies and local or international regulation Stay informed about regional regulatory changes and updates, and implement necessary adjustments to the QMS. Business Support Join the leadership team to ensure compliance of all Intuitive Surgical Ltd activities with applicable regulation; guide and influence operational decisions accordingly Represent Intuitive Surgical with competent authorities (eg MHRA, HPRA) and manufacturer associations (eg ABHI, IBEC) to develop and strengthen partnerships, and monitor and implement regulatory trends Support public procurement activities and customer satisfaction by ensuring timely and accurate RAQA input Additional activities Other projects may be assigned as necessary Travel: up to 20% #J-18808-Ljbffr
Contact Detail:
Intuitive Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior RAQA Manager
✨Tip Number 1
Familiarise yourself with the UK medical device regulations and the specific requirements for being a UK Responsible Person. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance.
✨Tip Number 2
Network with professionals in the regulatory affairs and quality assurance sectors, especially those who work with medical devices. Attend industry events or webinars to connect with potential colleagues and learn about current trends and challenges in the field.
✨Tip Number 3
Stay updated on recent changes in regulations and guidelines from authorities like the MHRA and HPRA. Being knowledgeable about the latest developments will give you an edge during discussions and show that you are proactive in your field.
✨Tip Number 4
Prepare to discuss your experience in managing quality management systems and regulatory compliance during interviews. Be ready to provide examples of how you've successfully navigated challenges in previous roles, as this will highlight your suitability for the Senior RAQA Manager position.
We think you need these skills to ace Senior RAQA Manager
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Senior RAQA Manager position. Make sure you understand the key responsibilities and required skills, particularly around regulatory compliance and quality management systems.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory affairs and quality assurance. Emphasise your previous roles that involved compliance with medical device regulations and your ability to liaise with government bodies.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention specific experiences that align with the responsibilities listed, such as managing quality systems or working with regulatory authorities.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail.
How to prepare for a job interview at Intuitive
✨Understand Regulatory Frameworks
Familiarise yourself with the UK medical device regulations and the specific requirements for being a UK Responsible Person. This knowledge will demonstrate your expertise and readiness to manage compliance effectively.
✨Showcase Your Leadership Skills
As a Senior RAQA Manager, you'll be part of the leadership team. Be prepared to discuss your experience in guiding teams and influencing operational decisions, highlighting any successful projects you've led in the past.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world situations. Think of examples where you've managed nonconformance or navigated regulatory changes, and be ready to explain your thought process.
✨Demonstrate Cross-Functional Collaboration
This role requires liaising with various teams. Prepare to discuss how you've successfully collaborated with sales, marketing, and service teams in previous roles, showcasing your ability to work across functions.
