Regulatory Affairs Specialist in Cambridge

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.

Duties & Responsibilities:

• Plan, prepare and submit regulatory applications and technical documentation for TidalSense medical 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 communications 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.

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:

• Applicants must have the existing right to work in the UK. We cannot provide sponsorship for overseas applicants requiring entry clearance. We are, however, able to support sponsorship for internal transfers or candidates currently on a Graduate Visa transitioning to a Skilled Worker Visa.
• Will need to be able to work in person in the Cambridge office at least 3 days / week (but ideally more).

Salary: £55,000-85,000 (depending on experience). TidalSense operates a fair pay structure to ensure our colleagues are paid equitably and competitively for their skill, expertise and experience. Successful candidates will be offered this role at the appropriate grade, based on both their resume experience and our judgement of their performance level through the assessment process. We are open to interviewing more junior candidates as well as those who have more industry experience in role.

Additional benefits include:

• 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.