At a Glance
- Tasks: Lead regulatory strategy and compliance for medical devices across Europe.
- Company: Join a pioneering medtech company focused on making a difference.
- Benefits: Competitive salary, career growth, and a chance to impact healthcare.
- Other info: Dynamic role with opportunities to mentor and lead cross-functional teams.
- Why this job: Shape the future of medical devices while ensuring market access and compliance.
- Qualifications: 8-12+ years in Regulatory Affairs with EU MDR expertise.
The predicted salary is between 60000 - 80000 £ per year.
The Senior Regulatory Affairs Manager will lead regulatory strategy and compliance activities across the EU, with a strong focus on enabling commercial success through effective tender participation and market access. This role requires deep expertise in EU MDR, CE marking, EUDAMED, and UDI, along with hands-on experience working with Notified Bodies and regulatory authorities.
The individual will act as a strategic partner to Commercial, Contracts, and cross-functional teams, providing regulatory insight to interpret complex tender requirements, identify compliance gaps, and develop practical solutions to win business. This role demands strong technical knowledge in EU labeling, eIFU, and promotional compliance, as well as the ability to implement processes, train teams, and translate evolving regulations into actionable business strategies.
A successful candidate will combine regulatory expertise, business acumen, and strategic thinking to drive compliant growth, ensure competitive positioning, and support sustainable expansion across European markets.
Duties & Responsibilities:
- Lead and execute regulatory strategy to support market access and commercial growth across Europe
- Drive regulatory support for tenders, including requirement review, gap analysis, and preparation of compliant documentation
- Partner with Commercial and Contracts teams to enable competitive, compliant, and timely tender submissions
- Manage CE marking, EU MDR compliance, and full product lifecycle activities (registrations, renewals, variations)
- Serve as primary interface with Notified Bodies and Competent Authorities for submissions, audits, and inspections
- Oversee setup and compliance of EU distributors, importers, and Authorized Representatives in accordance with MDR
- Ensure compliance with EUDAMED requirements, including actor registration, device registration, and vigilance data submissions
- Lead implementation and maintenance of UDI frameworks, ensuring compliance with EU MDR UDI requirements and alignment with global UDI systems (e.g., FDA, IMDRF)
- Act as SME for EU labeling, eIFU, and advertising/promotional (Ad/Promo) compliance
- Develop and maintain labeling procedures, governance, and training programs to ensure ongoing compliance
- Identify regulatory gaps and develop pragmatic solutions to meet tender and market requirements
- Translate evolving EU regulations into clear business actions and implementation plans
- Collaborate cross-functionally (Quality, Clinical, R&D, Supply Chain) to deliver regulatory outcomes
- Drive regulatory process improvements, system utilization (RIM/eQMS), and audit readiness
- Direct, plan, delegate and manage department budget and staff
Minimum experience:
- 8–12+ years of Regulatory Affairs experience in the medical device industry, with strong focus on EU regulations (EU MDR 2017/745)
- Proven experience with CE marking, Notified Body interactions, and EU regulatory submissions
- Hands-on experience with EUDAMED and UDI implementation, including alignment with global UDI frameworks
- Demonstrated experience supporting EU tenders, including regulatory documentation, gap assessments, and compliance strategies
- Experience with EU distributor, importer, and Authorized Representative setup and compliance
- Strong expertise in EU labeling, eIFU, and Ad/Promo compliance, including procedure development and training
- Solid knowledge of ISO 13485 and FDA QSR, with experience in international regulatory filings
- Strong cross-functional collaboration with Commercial, Contracts, Quality, and R&D teams
- Excellent communication, analytical, and problem-solving skills, with ability to translate regulatory requirements into business actions
- Self-driven, hands-on leader with strong execution focus, attention to detail, 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 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, Regulatory Affairs in Basingstoke employer: Masimo
Masimo is an exceptional employer that fosters a collaborative and innovative work culture, empowering employees to make a meaningful impact in the medical device industry. With a strong commitment to professional development, we offer extensive growth opportunities and support for continuous learning, ensuring our team members thrive in their careers. Located in a dynamic environment, we provide unique advantages such as access to cutting-edge technology and a focus on regulatory excellence, making us a leader in market access and compliance across Europe.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Manager, Regulatory Affairs in Basingstoke
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those who have experience with EU MDR and CE marking. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EUDAMED and UDI frameworks. Be ready to discuss how you've tackled compliance challenges in the past. We want to see your strategic thinking in action!
✨Tip Number 3
Showcase your cross-functional collaboration skills. Highlight experiences where you partnered with commercial or quality teams to drive regulatory success. This is key for roles that require teamwork across departments.
✨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 about their job search.
We think you need these skills to ace Sr Manager, Regulatory Affairs in Basingstoke
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience with EU MDR, CE marking, and EUDAMED. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant expertise!
Showcase Your Strategic Thinking:In your application, emphasise your ability to develop regulatory strategies that support commercial growth. We’re looking for someone who can think outside the box and provide practical solutions, so share examples of how you've done this in the past.
Highlight Cross-Functional Collaboration:Since this role involves working closely with various teams, make sure to mention your experience collaborating with Commercial, Contracts, and Quality teams. We love seeing candidates who can bridge gaps and drive results across departments!
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at Masimo
✨Know Your Regulations Inside Out
Make sure you brush up on EU MDR, CE marking, EUDAMED, and UDI before the interview. Being able to discuss these topics confidently will show that you have the deep expertise required for the role.
✨Prepare Real-World Examples
Think of specific instances where you've successfully navigated regulatory challenges or led compliance activities. Sharing these stories will demonstrate your hands-on experience and strategic thinking.
✨Understand the Business Side
Since this role involves partnering with Commercial and Contracts teams, be ready to discuss how regulatory insights can drive business success. Show that you can translate complex regulations into actionable strategies that support market access.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory strategy and how they approach tender submissions. This not only shows your interest but also your understanding of the role's impact on commercial growth.
