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For Companies At a Glance
- Tasks: Lead regulatory affairs for a major Medical Device organisation across EMEA.
- Company: Join Elemed, Europe's top MedTech recruiter with a focus on innovation.
- Benefits: Be part of a diverse team and contribute to life-changing medical devices.
- Why this job: Make a real impact in the MedTech space while managing complex projects.
- Qualifications: Experience in regulatory affairs and knowledge of European frameworks required.
- Other info: Opportunity for career growth in a dynamic and supportive environment.
The predicted salary is between 48000 - 72000 £ per year.
If you are a Senior Regulatory Affairs Consultant with expertise in complex business transitions, we have a critical role for you. This is a unique opportunity to lead the RA/QA workstreams for a major Medical Device organisation.
Responsibilities
- Provide project management for the seamless transition of RA, QA, and PMS activities across EMEA.
- Manage Regional Compliance: Oversee OEM regional work, including SKU-related verification and tri-partite agreements for EAR/CHRP/UKRP transitions.
- Facilitate change notification assessments, labelling updates, and de-registrations with MDR and Dutch MDD Competent Authorities.
- Manage MDR re-verification and local re-registrations.
- Update internal document repositories and ERP systems to reflect ongoing labelling and regulatory changes.
- Proven experience managing complex portfolios within the MedTech space.
- Deep knowledge of European regulatory frameworks; specific experience with Quality Agreements.
- Ability to manage fluctuating workloads and strict timelines.
- Familiarity with ERP systems (SAP/Oracle).
- Fluent English with the ability to coordinate between various stakeholders (PMS, Quality, and Regional teams).
How to apply
If you are interested in this high-impact consultancy role, please send your application directly.
Note
Please note: Only candidates meeting the requirements set out in the role profile above will be considered. Due to the high volume of applications, if you do not hear from us after 10 days, please consider your application unsuccessful.
About Elemed
Elemed is Europe’s leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.
Awards
We won Best International Recruitment Agency at the Recruiter Awards 2021. At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.
Equality
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Senior Manager Regulatory Affairs employer: elemed
Contact Detail:
elemed Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to your connections in the MedTech space and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of European regulatory frameworks. Be ready to discuss your experience with Quality Agreements and how you've managed complex portfolios in the past. Show them you’re the expert they need!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. Check out our website for roles that match your skills, especially in Regulatory Affairs. We’ve got some exciting opportunities waiting for you!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to show you were engaged and are genuinely interested in the role.
We think you need these skills to ace Senior Manager Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in regulatory affairs, especially in the MedTech space. We want to see how your skills align with the specific responsibilities mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share your passion for regulatory affairs and any relevant projects you've managed. This is your chance to shine!
Showcase Your Project Management Skills: Since project management is key for this role, be sure to include examples of how you've successfully managed complex portfolios and transitions in your previous roles. We love seeing real-life applications of your skills!
Apply Through Our Website: To make sure your application gets the attention it deserves, apply directly through our website. It’s the best way for us to keep track of your application and ensure you’re considered for this exciting opportunity!
How to prepare for a job interview at elemed
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of European regulatory frameworks, especially around MDR and Quality Agreements. Being able to discuss specific examples from your experience will show that you’re not just familiar with the theory but have practical insights too.
✨Showcase Your Project Management Skills
Prepare to talk about your experience managing complex portfolios and how you've successfully navigated transitions in RA/QA activities. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your project management prowess.
✨Familiarise Yourself with ERP Systems
Since familiarity with ERP systems like SAP or Oracle is key, be ready to discuss your experience with these tools. If you’ve used them to update document repositories or manage compliance, share those stories to demonstrate your technical skills.
✨Communicate Effectively
As this role involves coordinating between various stakeholders, practice articulating your thoughts clearly and concisely. Think about how you can convey complex regulatory information in a way that’s easy for others to understand, showcasing your communication skills.
