At a Glance
- Tasks: Lead regulatory submissions for innovative respiratory tech and ensure compliance across global markets.
- Company: Join TidalSense, a pioneering respiratory technology company transforming healthcare.
- Benefits: Enjoy flexible hours, hybrid work, generous leave, and personal development support.
- Other info: Collaborative environment with opportunities for growth and mentorship.
- Why this job: Make a real impact in healthcare while working with cutting-edge AI-driven medical devices.
- Qualifications: 5+ years in regulatory affairs with experience in medical device submissions.
The predicted salary is between 55000 - 85000 € 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.
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.
Duties & Responsibilities
- Plan, prepare and submit regulatory applications and technical documentation for TidalSense medicinal devices in priority markets (initially USA and EU but also Canada, Middle‑East, Brazil and China)
- Author, review and maintain technical documentation in accordance with applicable regulations and internal procedures
- Consult with external agencies to support strategy development, advice, and audits, and support audit and inspection readiness
- Serve as the primary point of contact with regulatory bodies, participating in meetings and managing correspondence with these agencies/bodies, and coordinating external audits
- Monitor global regulatory requirements and guidance for key markets, summarising changes and communicating impact and recommendations to internal stakeholders
- Project manage regulatory projects to ensure they are delivered on time and on budget
- Act as a subject matter expert within the organisation for regulatory affairs matters, ensuring regulatory requirements are considered in the entire medical device lifecycle
- Manage internal post‑market surveillance processes and mandatory regulatory post‑market submissions (e.g. PSURs and Trend Reports for the EU)
Skills & Competencies
- Technical writing – the ability to write clear, concise, regulatory documents
- Excellent written and verbal communication skills
- Attention to detail
- Direct, recent experience successfully developing and delivering FDA clearance / grant (510(k) or de novo)
- Knowledge of the latest FDA cybersecurity requirements and experience in translating them to secure design
- Proficiency in application of ISO 13485, 21 CFR 820, ISO 14971, IEC 62304, IEC 60601‑1 series (IEC 62366 desirable)
- Strong regulatory project management skills and ability to deliver cross‑functional projects on time
- Views Generative AI and automation tools as a force multiplier for their own productivity and is eager to pioneer new workflows in a regulated healthcare environment
- Willingness to learn and develop processes and personal skills
Qualifications & Experience – Essential
- Bachelor’s degree (or higher) in STEM (or related) field
- At least 5 years of experience in a regulatory affairs role within the medical device industry with hands‑on experience preparing and managing regulatory submissions for multiple international markets
- Experience with successful certification of SaMD devices at class II (or class III)
- Demonstrated success with FDA de novo or 510(k) submission through the eSTAR programme
- Experience with successful registration / approvals in at least two of Canada, EU, Japan, Brazil, Middle‑East, China
- Experience with project managing regulatory projects
- Experience working with global regulatory consultants, country representatives, or distributors to obtain and maintain registrations
- Experience working in a fast‑paced, growth‑stage organisation, with comfort operating independently and building and developing processes as the company grows
Qualifications & Experience – Desirable
- Direct experience leading FDA de novo submissions
- Experience with successful EU MDR submissions at class IIa (or higher) and/or MDSAP
- Formal Regulatory Affairs or Cybersecurity certifications
Other Requirements
- Legally eligible to work in the UK without sponsorship; sponsorship may be offered after probation
- Will need to work in person in the Cambridge office at least 3 days a week (ideally more)
Salary £55,000‑85,000 (depending on experience)
Benefits
- Flexible working hours to support your work preferences
- Hybrid working as per requirements above
- 25 days annual leave + 8 public holidays
- Pension: TidalSense contributes 5% of qualified earnings (increasing to 6% of base pay from H2 2026)
- Private health insurance (from H2 2026)
- Annual performance‑based bonus
- Discretionary share options scheme
- Work from abroad for 1 week per year
- Buy / sell up to 5 days annual leave (pro‑rated)
- Individual personal development budget + dedicated development days
- Mental Health support: wellbeing support and free 24/7 access to qualified counsellors and advisors
- Coaching and mentoring
- Team events and celebrations
- Beautiful award‑winning Cambridge UK office stocked with quality drinks & snacks
Regulatory Affairs Specialist in Cambridge employer: TidalSense
TidalSense is an exceptional employer, offering a dynamic work environment in the heart of Cambridge, where innovation meets purpose. With a strong commitment to employee growth, TidalSense provides flexible working hours, generous annual leave, and a personal development budget, ensuring that every team member can thrive both personally and professionally. The company's mission to revolutionise respiratory care not only fosters a collaborative culture but also allows employees to contribute to meaningful advancements in global healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Cambridge
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs space, especially those who work at TidalSense or similar companies. LinkedIn is your best mate here—send connection requests and engage with their posts to get noticed.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA regulations and ISO standards. We want you to be the go-to person for regulatory questions, so show off your expertise and how it aligns with TidalSense's mission.
✨Tip Number 3
Don’t just wait for job openings—create your own opportunities! If you’re passionate about TidalSense’s work, consider reaching out directly to express your interest and share how you can contribute to their regulatory projects.
✨Tip Number 4
Stay updated on global regulatory changes that could impact TidalSense. Subscribe to relevant newsletters or join forums. This shows initiative and keeps you ahead of the game when discussing your insights during interviews.
We think you need these skills to ace Regulatory Affairs Specialist in Cambridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Regulatory Affairs Specialist role. Highlight your relevant experience in regulatory submissions and technical writing, as this will show us you understand what we're looking for.
Showcase Your Skills:Don’t just list your qualifications; demonstrate how your skills align with our needs. If you've got experience with FDA submissions or ISO standards, let us know how you've applied that knowledge in past roles.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, especially in regulatory affairs, so make sure your documents are easy to read and free of jargon.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows us you're keen on joining our team!
How to prepare for a job interview at TidalSense
✨Know Your Regulations
Familiarise yourself with the key regulations and standards relevant to the role, such as ISO 13485 and 21 CFR 820. Being able to discuss these in detail will show your expertise and readiness to handle regulatory submissions.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed regulatory projects in the past. Highlight your ability to deliver on time and within budget, as this is crucial for the role at TidalSense.
✨Communicate Clearly
Practice articulating complex regulatory concepts in a clear and concise manner. Strong communication skills are essential, so be ready to demonstrate your ability to convey technical information effectively.
✨Stay Updated on Industry Trends
Research the latest trends in regulatory affairs, especially regarding AI-driven medical devices. Showing that you're proactive about industry changes will impress interviewers and demonstrate your commitment to continuous learning.
