At a Glance
- Tasks: Lead regulatory strategy and compliance for medical devices across Europe.
- Company: Join a leading medtech company focused on innovation and growth.
- Benefits: Competitive salary, career development, and a collaborative work environment.
- Other info: Dynamic role with opportunities for leadership and cross-functional collaboration.
- Why this job: Make a real impact in the medical device industry while driving compliance and market access.
- Qualifications: 8-12+ years in Regulatory Affairs with strong 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.
Masimo is an equal opportunities employer.
Senior Manager, Regulatory Affairs in Basingstoke employer: Meeveem Limited
Masimo is an exceptional employer that fosters a collaborative and innovative work culture, empowering employees to drive regulatory excellence in the medical device industry. With a strong commitment to professional development, employees benefit from comprehensive training programs and opportunities for growth, particularly in the dynamic European market. Located in a vibrant area, Masimo offers a unique chance to be at the forefront of regulatory affairs while contributing to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Regulatory Affairs in Basingstoke
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Meeveem Limited looking for candidates who are engaged and informed.
We think you need these skills to ace Senior Manager, Regulatory Affairs in Basingstoke
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Meeveem Limited. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Meeveem Limited
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Meeveem Limited’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
