At a Glance
- Tasks: Lead regulatory submissions and ensure compliance for innovative medical products.
- Company: Join a forward-thinking medical technology business with a remote-first culture.
- Benefits: 100% remote work, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and career development.
- Why this job: Make a real impact in global healthcare by driving regulatory strategies.
- Qualifications: Experience with EU MDR, FDA 510(k), and a background in medical devices.
The predicted salary is between 50000 - 65000 € per year.
Are you an experienced regulatory professional looking for your next long-term career move? You will need SaMD and FDA experience for this one! 100% remote. I am partnering with an innovative medical technology business to find a dedicated Regulatory Affairs Specialist to join their growing RAQA team on a permanent & 100% remote basis!
In this pivotal role, you will champion global regulatory compliance, drive regulatory strategy, and ensure seamless market access for cutting-edge products across multiple regions.
What You Will Be Doing:
- Leading and managing critical regulatory submissions, with a primary focus on EU MDR technical files and FDA 510(k).
- Acting as the Person Responsible for Regulatory Compliance (PRRC) when required.
- Producing and maintaining essential clinical (CEP, CER) and post-market surveillance (PMSP, PSUR) documentation.
- Guiding cross-functional Product and Engineering teams to embed regulatory requirements directly into the product development lifecycle.
- Managing vigilance activities and driving new regional product registrations.
What You Bring to the Table:
- A solid regulatory affairs background within the medical device sector.
- Proven, hands-on success with EU MDR and FDA 510(k) submissions.
- Deep working knowledge of ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, and ISO 62366-1.
- A relevant degree in Life Sciences, Biomedical Engineering, Computer Science, or RA.
- Direct experience with Software as a Medical Device (SaMD) and an understanding of medical imaging modalities.
If you are ready to take ownership of global regulatory strategies in a forward-thinking, collaborative environment, let's talk!
Regulatory Affairs Specialist in Newcastle upon Tyne employer: LinkedIn
Join a pioneering medical technology company that values innovation and collaboration, offering a fully remote work environment that promotes work-life balance. As a Regulatory Affairs Specialist, you will have the opportunity to lead critical regulatory submissions while benefiting from a culture that prioritises employee growth and development through continuous learning and support. With a focus on cutting-edge products and global market access, this role provides a meaningful chance to make a significant impact in the medical device sector.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Newcastle upon Tyne
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those with SaMD and FDA experience. A friendly chat can lead to insider info about job openings that aren't even advertised yet!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR and FDA 510(k) submissions. We recommend creating a list of key points you want to discuss, showcasing your hands-on success in these areas.
✨Tip Number 3
Don’t forget to highlight your experience with cross-functional teams during interviews. Show how you've embedded regulatory requirements into product development – it’s a game-changer for roles like this!
✨Tip Number 4
Apply through our website for a smoother process! We’re all about making it easy for you to land that dream job. Plus, it shows you're serious about joining our innovative team!
We think you need these skills to ace Regulatory Affairs Specialist in Newcastle upon Tyne
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience with SaMD and FDA submissions. We want to see how your background aligns with the role, so don’t be shy about showcasing your relevant skills!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your experience can help us drive compliance and market access for our innovative products.
Showcase Your Technical Knowledge:Mention your familiarity with EU MDR, ISO standards, and any specific regulatory frameworks you've worked with. We love seeing candidates who understand the nitty-gritty of regulatory processes!
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 this exciting opportunity in our RAQA team!
How to prepare for a job interview at LinkedIn
✨Know Your Regulations
Make sure you brush up on the latest EU MDR and FDA 510(k) requirements. Being able to discuss specific regulations and how they apply to the role will show your expertise and commitment to regulatory affairs.
✨Showcase Your Experience with SaMD
Since this role requires experience with Software as a Medical Device, prepare examples of your past work in this area. Be ready to explain how you've navigated regulatory challenges and ensured compliance in previous projects.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory scenarios. Think about past experiences where you had to manage submissions or compliance issues, and be ready to share those stories in detail.
✨Engage with Cross-Functional Teams
Highlight your ability to work with Product and Engineering teams. Prepare to discuss how you've successfully embedded regulatory requirements into product development processes, as collaboration is key in this role.
