At a Glance
- Tasks: Manage regulatory submissions and support change control in a collaborative team.
- Company: Growing medical device company with exciting projects and a supportive culture.
- Benefits: Competitive salary, remote work, and potential for permanent position.
- Other info: Fully remote role with excellent career growth opportunities.
- Why this job: Join a dynamic team during an exciting phase of MDR certification.
- Qualifications: 4–7 years in medical device regulatory affairs and proactive attitude.
The predicted salary is between 55000 - 60000 £ per year.
We're recruiting on behalf of a growing medical device company for a Senior RA Specialist to cover maternity leave, with a strong likelihood of becoming a permanent role. This is a broad, hands-on position sitting within a collaborative regulatory affairs team. You'll be picking up change control, submissions, competent authority and notified body correspondence, PMS reporting, and mentoring junior team members. The company is in an exciting phase as MDR certification is incoming for one of their brands, which means plenty of meaningful work ahead.
What the role involves:
- Regulatory submissions across FDA 510(k), CE Mark, UKCA, Health Canada and international markets.
- Change control support.
- Lifecycle maintenance including PMS data collection and PSUR writing.
- Biocompatibility reviews.
- Representing RA in cross-functional meetings.
- Being a go-to resource for the wider team.
What they're looking for:
- 4–7 years in medical device regulatory affairs.
- Solid working knowledge of EU MDR, ISO 13485, FDA QSR.
- Someone who's worked across a broad remit — ideally from a small or mid-size company background where you've had to turn your hand to everything.
- FDA experience is a plus but not essential.
- More than anything, they want someone who gets stuck in. Takes initiative. Works well remotely. Keeps people in the loop without being chased.
- If you're the type who sees something that needs doing and just does it — this will suit you.
The details:
- 12-month fixed-term contract, fully remote.
- £55,000–£60,000 depending on experience.
- July/August start preferred, with a thorough handover before the person you're covering goes on leave.
- Real potential to go permanent and this is budgeted as a headcount addition for next year.
If this sounds like you, apply below.
Senior Regulatory Specialist employer: CAPU Search
Join a dynamic and innovative medical device company that values collaboration and initiative, offering a supportive remote work environment. With a strong focus on employee growth, you'll have the opportunity to mentor junior team members while engaging in meaningful projects as the company prepares for MDR certification. Enjoy competitive compensation and the potential for a permanent role in a thriving sector, making this an excellent place for those looking to make a significant impact in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Specialist
✨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 Senior Regulatory Specialist role. You never know who might have the inside scoop on opportunities or can put in a good word for you.
✨Tip Number 2
Get your online presence sorted! Make sure your LinkedIn profile is up-to-date and showcases your experience in regulatory affairs. Join relevant groups and engage with posts to get noticed by potential employers.
✨Tip Number 3
Prepare for those interviews! Research the company and its products, especially their upcoming MDR certification. Be ready to discuss how your experience aligns with their needs and how you can contribute to their team.
✨Tip Number 4
Don't forget to apply through our website! We make it easy for you to submit your application directly, and it shows you're serious about the role. Plus, it helps us keep track of your application better!
We think you need these skills to ace Senior Regulatory Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your regulatory affairs experience, especially with medical devices, and any relevant certifications. We want to see how you fit into our team!
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. Mention your hands-on experience with regulatory submissions and how you’ve taken initiative in previous roles. Let us know why you’re excited about joining our team!
Showcase Your Team Spirit:Since this role involves mentoring and collaboration, make sure to highlight your teamwork skills. Share examples of how you've supported colleagues or led projects in a remote setting. We love candidates who can keep everyone in the loop without being chased!
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any updates. Plus, we can’t wait to see what you bring to the table!
How to prepare for a job interview at CAPU Search
✨Know Your Regulations
Make sure you brush up on your knowledge of EU MDR, ISO 13485, and FDA QSR. Be ready to discuss how your experience aligns with these regulations and how you've applied them in previous roles. This will show that you're not just familiar with the terms but can also navigate the complexities of regulatory affairs.
✨Show Your Initiative
Since the company is looking for someone who takes initiative, prepare examples from your past where you identified a problem and took action without being prompted. This could be anything from streamlining a process to mentoring a junior team member. Highlighting these experiences will demonstrate that you’re proactive and ready to contribute.
✨Be Ready for Cross-Functional Collaboration
The role involves representing regulatory affairs in cross-functional meetings, so think about times when you've successfully collaborated with other departments. Prepare to discuss how you communicated complex regulatory information to non-regulatory colleagues, as this will showcase your ability to bridge gaps and work effectively in a team.
✨Prepare for Change Control Discussions
Given that change control support is a key part of the role, come prepared with specific examples of how you've managed change control processes in the past. Discuss any challenges you faced and how you overcame them, as this will illustrate your hands-on experience and problem-solving skills in a regulatory context.
