At a Glance
- Tasks: Lead regulatory processes for innovative respiratory tech and ensure compliance in new markets.
- Company: Join TidalSense, a pioneering company transforming respiratory care with cutting-edge technology.
- Benefits: Be part of a passionate team with opportunities for growth and impact in healthcare.
- Other info: Dynamic start-up environment transitioning to scale-up, perfect for driven individuals.
- Why this job: Make a difference in global health by revolutionising respiratory medicine with your expertise.
- Qualifications: Experience in regulatory affairs for medical devices and a passion for healthcare innovation.
The predicted salary is between 40000 - 50000 € per year.
About TidalSense: TidalSense is a respiratory technology company with a mission to transform the diagnosis, monitoring and management of chronic respiratory conditions, such as asthma and COPD. The company has ambitions to enable a population‑scale change in respiratory care through global deployment of its technologies in both developed and developing countries with poor access to healthcare. TidalSense has launched the first‑of‑its‑kind AI‑driven (software medical device) diagnostic test for COPD which uses the company’s unique, patented, sensor technology embedded in the N‑Tidal Handset medical device.
We are seeking a regulatory affairs specialist with hands‑on experience delivering regulatory certification for software medical device products. We are at an exciting phase in our journey as we transition from a start‑up to a scale‑up. You will be joining a passionate, socially‑motivated and multi‑disciplinary team covering engineers, scientists, clinicians, designers, product and usability specialists. This is a unique opportunity for a driven and autonomous individual to support the delivery of TidalSense medical devices into new markets.
We are seeking someone who is comfortable working in a fast‑paced, agile, and diverse team environment, and who is also committed to our mission to revolutionise respiratory medicine.
Job Purpose: To own the execution of TidalSense’s global medical device programme, securing regulatory clearance within chosen territories in a timely manner while ensuring safe and compliant medical device development and maintenance (pre and post market). This role is responsible for preparing, submitting and maintaining regulatory filings for priority markets.
Regulatory Affairs Specialist employer: TidalSense limited
TidalSense is an exceptional employer that fosters a dynamic and inclusive work culture, where innovation meets social impact. As a Regulatory Affairs Specialist, you will be part of a passionate team dedicated to transforming respiratory care globally, with ample opportunities for professional growth and development in a fast-paced environment. Our commitment to employee well-being and the meaningful nature of our work makes TidalSense a truly rewarding place to advance your career.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory processes and the latest trends in respiratory technology. We recommend practising common interview questions with a friend to boost your confidence.
✨Tip Number 3
Show your passion for the mission! When you get the chance to chat with potential employers, let them know why you care about transforming respiratory care. We believe that genuine enthusiasm can set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. We’re excited to see how you can contribute to our mission at TidalSense!
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your hands-on experience with regulatory certification for software medical devices, and don’t forget to showcase any relevant projects or achievements that align with our mission at TidalSense.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to express your passion for transforming respiratory care and how your skills can contribute to our exciting journey. Be sure to mention why you’re drawn to TidalSense and what makes you a great fit for our team.
Showcase Your Team Spirit:We love a collaborative spirit! In your application, share examples of how you've worked in diverse teams or fast-paced environments. This will show us that you’re ready to jump into our multi-disciplinary team and help us revolutionise respiratory medicine.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about TidalSense and our mission before you hit 'send'.
How to prepare for a job interview at TidalSense limited
✨Know Your Stuff
Make sure you brush up on the regulatory landscape for medical devices, especially software ones. Familiarise yourself with relevant regulations like the MDR and FDA guidelines. This will show that you're not just interested in the role but also understand the complexities involved.
✨Show Your Passion
TidalSense is all about transforming respiratory care, so let your enthusiasm shine through! Share any personal experiences or motivations that connect you to their mission. This can really set you apart from other candidates.
✨Prepare for Scenario Questions
Expect questions that ask how you'd handle specific regulatory challenges. Think of examples from your past experience where you successfully navigated regulatory hurdles. This will demonstrate your hands-on experience and problem-solving skills.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about TidalSense's future projects or how they plan to tackle regulatory challenges in new markets. This shows your genuine interest in the company and the role.
