At a Glance
- Tasks: Lead regulatory submissions and ensure compliance for innovative medical technology products.
- Company: Join a forward-thinking medical tech company with a collaborative culture.
- Benefits: 100% remote work, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with a focus on Software as a Medical Device (SaMD) and career advancement.
- Why this job: Make a real impact in global regulatory strategies for cutting-edge medical devices.
- Qualifications: Experience with EU MDR, FDA 510(k), and a background in Life Sciences or Biomedical Engineering.
The predicted salary is between 50000 - 70000 € 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! 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 Manchester employer: LinkedIn
Join a pioneering medical technology company that values innovation and collaboration, offering a fully remote work environment that promotes flexibility and work-life balance. As a Regulatory Affairs Specialist, you will have the opportunity to lead critical regulatory submissions and drive compliance strategies, all while benefiting from a supportive culture that prioritises employee growth and development in the rapidly evolving field of medical devices.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Manchester
✨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 ISO standards during interviews. We know how crucial they are in regulatory affairs, so be ready to share specific examples of how you've applied them in your previous roles.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect with us directly.
We think you need these skills to ace Regulatory Affairs Specialist in Manchester
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 expertise can help us drive compliance and market access for our innovative products.
Showcase Your Achievements:When detailing your experience, focus on specific achievements in regulatory submissions and compliance. Numbers and outcomes speak volumes, so let us know how you’ve made an impact in your previous roles!
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 growing 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) regulations. Being able to discuss specific examples of your experience with these submissions will show that you're not just familiar, but truly knowledgeable.
✨Showcase Your SaMD Experience
Since this role requires direct experience with Software as a Medical Device, prepare to share detailed stories about your past projects. Highlight how you navigated regulatory challenges and ensured compliance in your previous roles.
✨Prepare for Technical Questions
Expect some technical questions related to ISO standards like ISO 13485:2016 and IEC 62304. Brush up on these topics and be ready to explain how you've applied them in your work to demonstrate your expertise.
✨Emphasise Collaboration Skills
This position involves guiding cross-functional teams, so be prepared to discuss how you've successfully collaborated with product and engineering teams in the past. Share examples that highlight your ability to embed regulatory requirements into the product development lifecycle.
