At a Glance
- Tasks: Lead regulatory and quality operations to ensure compliance and support business growth.
- Company: Join a leading medical device company focused on innovation and compliance.
- Benefits: Competitive salary, professional development, and opportunities for career advancement.
- Other info: Dynamic role with opportunities to mentor and lead a talented team.
- Why this job: Make a real impact in the medical device industry while driving operational excellence.
- Qualifications: 8-12+ years in Regulatory Affairs or Quality Assurance in medical devices required.
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
- 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
- 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
Qualifications:
- 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
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.
Self‑driven leader with strong attention to detail, execution focus, and ability to manage multiple priorities.
Sr Manager, Quality & Regulatory Operations in Basingstoke employer: Masimo Corporation
As a leading employer in the medical device industry, we offer a dynamic work environment that fosters innovation and collaboration. Our commitment to employee growth is evident through comprehensive training programmes and mentorship opportunities, ensuring that our team members thrive in their careers. Located in a vibrant area, we provide a supportive culture that values compliance and operational excellence, making us an ideal choice for professionals seeking meaningful and rewarding employment.
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 folks in the industry, attend relevant events, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory and quality challenges, and think about how your experience aligns with their needs. This will help you stand out as a candidate who gets it!
✨Tip Number 3
Practice your pitch! Be ready to explain how your background in regulatory affairs and quality assurance makes you the perfect fit for the role. Keep it concise but impactful, highlighting your key achievements and expertise.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our platform.
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 highlight your experience in regulatory affairs and quality assurance. We want to see how your skills align with the specific requirements mentioned in the job description, so don’t hold back on showcasing your relevant achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Sr Manager role. We love seeing candidates who can connect their past experiences to our needs, so be sure to mention any relevant projects or successes.
Showcase Your Leadership Skills:Since this role involves leading teams, make sure to highlight your leadership experience. We’re looking for someone who can mentor and develop others, so share examples of how you've successfully led teams or projects in the past.
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’re considered for the role. Plus, it gives you a chance to explore more about what we do at StudySmarter!
How to prepare for a job interview at Masimo Corporation
✨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 Quality Management Skills
Prepare examples that highlight your hands-on experience with Quality Management Systems, especially ISO 13485. Talk about specific CAPA processes or audits you've led, and how you ensured compliance while driving operational excellence.
✨Collaborate Like a Pro
This role requires cross-functional collaboration, so think of instances where you've partnered with teams like Commercial or R&D. Be ready to explain how you translated regulatory requirements into actionable steps for different departments.
✨Demonstrate Leadership and Mentorship
If you've got people leadership experience, be sure to share how you've mentored team members and driven accountability. Discuss your approach to developing training programs and how you've fostered a culture of continuous improvement within your team.
