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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 a dynamic work environment with opportunities for travel and professional growth.
- Why this job: Make a real impact in healthcare while collaborating with global teams and government bodies.
- Qualifications: 8+ years in medical devices, with strong knowledge of EU and UK regulations required.
- Other info: Opportunity to influence operational decisions and support public procurement activities.
The predicted salary is between 54000 - 84000 £ per year.
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
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Fulfill the role of UK Responsible Person contact and site management representative
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Responsible for ensuring compliance of the quality system activities (Nonconformance management, audit/inspection, economic operator obligations, post market surveillance) in the target markets
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Partner with domestic and international teams to develop and execute quality management system strategies in accordance with corporate policies and local or international regulation
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Stay informed about regional regulatory changes and updates, and implement necessary adjustments to the QMS.
Business Support
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Join the leadership team to ensure compliance of all Intuitive Surgical Ltd activities with applicable regulation; guide and influence operational decisions accordingly
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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
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Support public procurement activities and customer satisfaction by ensuring timely and accurate RAQA input
Additional activities
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Other projects may be assigned as necessary
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Travel: up to 20%
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At least 8+ years’ experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management, quality manufacturing or regulatory affairs
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A Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
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Deep knowledge of EU MDR 2017/745/EU, UK MDR 2002 and ISO 13485:2016
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Ability to work autonomously and exercise daily judgment based on above regulatory knowledge.
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Demonstrated organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for results
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Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
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Orientation for work result details, with emphasis on accuracy and completeness
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Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
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Language: Fluent English
Preferred Knowledge, Skills, and Experience:
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Lead auditor certification for ISO 13485 and knowledge of WW regulations
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RAC certification is a plus
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Team management experience of small team size associated with goals objectives definition / people development.
Senior RAQA Manager employer: Intuitive
Contact Detail:
Intuitive Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior RAQA Manager
✨Tip Number 1
Make sure to familiarize yourself with the UK medical device regulations and the specific requirements of the UK Responsible Person role. 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 medical device industry, especially those who have experience with regulatory affairs and quality management systems. Engaging with industry associations or attending relevant conferences can provide valuable insights and connections.
✨Tip Number 3
Stay updated on recent changes in EU MDR and UK MDR regulations. Being able to discuss current trends and how they impact the industry will show that you are proactive and knowledgeable, which is crucial for this role.
✨Tip Number 4
Prepare to discuss your experience in managing quality systems and regulatory compliance during the interview. Be ready to share specific examples of how you've successfully navigated challenges in these areas, as this will highlight your expertise and problem-solving skills.
We think you need these skills to ace Senior RAQA Manager
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Senior RAQA Manager position. Highlight your relevant experience in regulatory compliance, quality management systems, and your ability to liaise with various teams.
Tailor Your CV: Customize your CV to reflect your 8+ years of experience in the medical device industry. Emphasize your knowledge of EU MDR, UK MDR, and ISO 13485, as well as any leadership roles you've held.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and quality assurance. Mention specific examples of how you've successfully managed compliance and quality systems in previous roles.
Highlight Communication Skills: Since excellent verbal and written communication skills are crucial for this role, provide examples in your application that demonstrate your ability to distill complex information and present it clearly to different stakeholders.
How to prepare for a job interview at Intuitive
✨Showcase Your Regulatory Knowledge
Be prepared to discuss your deep understanding of EU MDR 2017/745/EU, UK MDR 2002, and ISO 13485:2016. Highlight specific examples from your past experience where you successfully navigated regulatory challenges.
✨Demonstrate Leadership Skills
Since this role involves joining the leadership team, share instances where you've led teams or projects. Emphasize your ability to influence operational decisions and ensure compliance with regulations.
✨Communicate Clearly and Effectively
Excellent verbal and written communication skills are crucial. Practice distilling complex regulatory information into clear, actionable insights. Be ready to present your ideas succinctly during the interview.
✨Prepare for Questions on Collaboration
This position requires liaising with various teams and external bodies. Prepare to discuss how you've successfully collaborated with sales, marketing, and regulatory authorities in the past, and how you can strengthen partnerships moving forward.
