Hybrid Regulatory Affairs Specialist

at TidalSense

• Job title: Regulatory Affairs Specialist
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Cyber Security
• Location requirements: Hybrid, Cambridge, United Kingdom

About the role

• Regulatory Affairs Specialist managing regulatory processes for TidalSense medical devices in various global markets. Preparing submissions and ensuring compliance in fast-paced healthcare environment.

Responsibilities

• 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.
• Plan, prepare and submit regulatory applications and technical documentation for TidalSense medial 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)

Requirements

• 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
• 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.
• 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

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% 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