At a Glance
- Tasks: Lead regulatory and quality operations to ensure compliance and support business growth.
- Company: Join a pioneering medical device company making a real difference in healthcare.
- Benefits: Competitive salary, career development, and the chance to work on impactful projects.
- Other info: Dynamic team environment with opportunities for mentorship and leadership development.
- Why this job: Be at the forefront of regulatory excellence and drive innovation in medical technology.
- Qualifications: 8-12+ years in Regulatory Affairs/Quality Assurance with strong EU regulatory knowledge.
The predicted salary is between 60000 - 80000 £ per year.
The Senior Manager, Quality & Regulatory Operations will lead regulatory and quality operations to support compliance, market access, and commercial success. This role combines regulatory expertise with quality systems leadership to ensure products, processes, and documentation meet EU and global requirements.
The individual will act as a key partner to Commercial, Contracts, and cross-functional teams to support tender readiness, interpret regulatory and quality requirements, identify gaps, and implement practical solutions. This role requires strong expertise in medical device regulatory frameworks, quality systems, labeling, and post-market compliance, along with the ability to drive operational excellence and audit readiness.
Duties & Responsibilities:
- Lead RA/QA operations strategy and execution to support compliance and business growth.
- Drive regulatory and quality support for tenders, including requirement review, gap assessment, and compliant documentation.
- Partner with Commercial and Contracts teams to enable timely and competitive tender submissions.
- Ensure compliance with applicable global regulatory and quality requirements.
- Ability to interface with Notified Bodies and Competent Authorities for audits, inspections, and compliance activities.
- Oversee EUDAMED compliance (actor registration, device data, vigilance) and support maintenance of regulatory records.
- Support implementation and maintenance of UDI frameworks, ensuring alignment with EU and global UDI requirements.
- Manage and improve Quality Management System (QMS) processes, including CAPA, change control, deviations, and audit readiness.
- Provide oversight and guidance on regulatory submissions and lifecycle activities, with working knowledge of submission requirements (no direct ownership required).
- Oversee setup and compliance of distributors, importers, and Authorized Representatives.
- Act as SME for labeling, eIFU, and Ad/Promo compliance, ensuring alignment with regulatory and quality standards.
- Develop and implement policies, procedures (SOPs), and training programs for regulatory and quality compliance.
- Identify regulatory and quality gaps and implement practical, compliant solutions to support business objectives.
- Translate regulatory and quality requirements into clear operational processes and business actions.
- Collaborate cross-functionally (Quality, Clinical, R&D, Supply Chain) to ensure alignment and execution.
- Drive continuous improvement, inspection readiness, and effective use of systems (RIM/eQMS).
- Lead, mentor, and develop team members, while driving accountability and execution.
Minimum experience:
- 8–12+ years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industry.
- Strong knowledge of EU MDR (2017/745), CE marking requirements, and European regulatory frameworks.
- Hands-on experience with EUDAMED and UDI implementation in alignment with global frameworks.
- Strong experience in Quality Management Systems (ISO 13485), including CAPA, audits, change control, and compliance processes.
- Experience with EU distributor, importer, and Authorized Representative compliance.
- Strong expertise in EU labeling, eIFU, and Ad/Promo compliance, including procedural development and training.
- Excellent communication, analytical, and problem-solving skills, with ability to translate requirements into operational execution.
- Self-driven leader with strong attention to detail, execution focus, and ability to manage multiple priorities.
Preferred experience:
- Experience in patient monitoring, hospital-based medical devices, digital health, or software-enabled medical technologies.
- 3–5+ years of people leadership or matrix leadership experience, including mentoring and influencing cross-functional teams.
- Experience working in EU-focused or global medtech organizations with exposure to multi-country quality and regulatory operations.
- Demonstrated ability to support commercial/tender strategy and business growth initiatives through regulatory leadership.
Education:
- Bachelor’s degree is required, preferably in life sciences, engineering, law, medicine, pharmacy, or another relevant scientific discipline.
- Graduate degree in a technical discipline or business management is preferred.
Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position? To learn more about us, please visit: www.masimo.com
Sr Manager, Quality & Regulatory Operations in Basingstoke employer: Masimo
At Masimo, we pride ourselves on being an exceptional employer that fosters a culture of innovation and collaboration. Our commitment to employee growth is evident through comprehensive training programs and leadership opportunities, ensuring that our team members thrive in their careers. Located in a dynamic environment, we offer competitive benefits and a supportive atmosphere where your contributions directly impact the success of our quality and regulatory operations.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Manager, Quality & Regulatory Operations in Basingstoke
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Sr Manager role. You never know who might have the inside scoop on openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your regulatory and quality knowledge. Make sure you can confidently discuss EU MDR, CE marking, and Quality Management Systems. We want you to shine when it comes to showcasing your expertise!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for opportunities that excite you and fit your skills. Tailor your approach to each company to show them why you’re the perfect fit.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Use this opportunity to reiterate your interest in the role and highlight how your experience aligns with their needs.
We think you need these skills to ace Sr Manager, Quality & Regulatory Operations in Basingstoke
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Sr Manager, Quality & Regulatory Operations. Highlight your experience in regulatory affairs and quality assurance, especially within the medical device industry. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share specific examples of how you've driven compliance and operational excellence in previous positions. We love a good story!
Showcase Your Leadership Skills:Since this role involves leading teams, make sure to highlight your leadership experience. Talk about how you've mentored others and driven accountability in past roles. We’re looking for someone who can inspire and lead us to success!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss any important updates. Plus, we love seeing applications come in through our own platform!
How to prepare for a job interview at Masimo
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU MDR, CE marking requirements, and EUDAMED compliance. Be ready to discuss how your experience aligns with these frameworks and how you've successfully navigated regulatory challenges in the past.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll need to demonstrate your ability to lead and mentor teams. Prepare examples of how you've developed team members and driven accountability in previous roles. Highlight any cross-functional collaboration you've been involved in.
✨Be Ready for Practical Problem-Solving
Expect questions that assess your ability to identify regulatory and quality gaps and implement solutions. Think of specific instances where you've translated complex requirements into actionable processes and be prepared to share those stories.
✨Communicate Clearly and Confidently
Strong communication skills are key for this role. Practice articulating your thoughts clearly, especially when discussing technical topics. Use examples from your experience to illustrate your points and ensure you convey your passion for quality and regulatory excellence.
