Digital Health Regulatory Affairs Manager

Job Description:

We're looking for a sharp, experienced, and commercially aware Digital Health Regulatory Affairs Manager to join our growing Governance, Risk & Compliance (GRC) team. This role is ideal for someone who thrives in regulated environments, understands the pressures facing digital health innovators, and can confidently guide clients through complex frameworks such as NHS DSPT, DTAC, EU MDR, US FDA, and ISO13485.

You'll operate at the intersection of cybersecurity, regulatory strategy, and medical device compliance — playing a central role in helping digital health and MedTech clients bring safe, secure, and compliant products to market.

This is a client-facing position, where you'll lead regulatory engagements, support technical and documentation reviews, and represent Periculo as a subject-matter expert across software as a medical device (SaMD) and AI as a medical device (AIaMD).

If you're passionate about digital health and want to make a real impact on how the next generation of medical technologies are deployed — we'd love to speak with you.

A day in the life:

• Start the morning with our Periculo Pulse, a quick-fire briefing on regulatory updates, market changes, and sector risks.
• Join a client call to outline a regulatory pathway for their SaMD/AIaMD product and identify compliance gaps against EU MDR or DTAC.
• Review and refine client documentation — from hazard analyses to QMS procedures — ensuring alignment with ISO 13485 and IEC standards.
• Work alongside our penetration testing and cybersecurity teams to ensure security controls are integrated into regulatory submissions.
• Lead a workshop on DTAC or FDA requirements, translating complex guidance into clear and actionable steps.
• Support a client preparing for an FDA pre-submission meeting, advising on evidence, labelling, risk management, and documentation completeness.
• Wrap up by updating client risk registers, preparing a regulatory roadmap, or reviewing new legislation that may impact digital health products.

Key Duties:

• Regulatory Strategy: Develop, lead, and implement regulatory strategies for digital health products across the NHS, UK, EU, and US markets.
• Client Guidance: Act as the primary regulatory advisor for client projects; communicate clearly, confidently, and persuasively.
• Framework Implementation: Support clients in achieving compliance with DTAC, DSPT, EU MDR, FDA (510(k)/De Novo), and ISO 13485.
• Documentation Review: Lead the review of QMS documents, hazard analyses, risk files, clinical evidence strategies, SBOMs/SOUP records, and cybersecurity documentation.
• Regulatory Submissions: Prepare and support technical file generation, FDA submissions, and MDR documentation packs.
• Cross-functional Collaboration: Work closely with penetration testers and security specialists to align regulatory and cybersecurity requirements.
• Standards Expertise: Interpret and apply standards such as IEC 62304, IEC , ISO 14971, IEC TR , NIST, and FDA cybersecurity guidance.
• Client Workshops: Deliver training, awareness sessions, and regulatory pathway workshops for digital health teams.
• Risk & Gap Assessments: Conduct gap analyses for DTAC, ISO standards, and regulatory frameworks to produce actionable improvement plans.
• Continuous Improvement: Stay current with emerging regulations (AI Act, evolving FDA guidance, NHS assurance updates) and ensure clients are ahead of the curve.

Skills & Qualifications:

Must Have:

• Experience in regulatory affairs within Digital Health, MedTech, or Software as a Medical Device (SaMD).
• Strong working knowledge of EU MDR, FDA 510(k)/De Novo pathways, and digital health standards.
• Experience with SaMD and/or AIaMD regulatory frameworks.
• Exceptional communication skills — able to simplify complex regulatory language for non-reg specialists.
• Confidence leading client meetings and presenting regulatory strategy.
• Strong attention to detail, documentation accuracy, and structured problem-solving.
• Ability to work cross-functionally with engineers, cybersecurity specialists, and QA teams.
• Willingness to learn and master emerging standards, guidance documents, and regulatory expectations as the digital health landscape evolves.

Nice to Have:

• RAC certification or similar regulatory qualification.
• ISO 13485 Lead Auditor qualification.
• Understanding of cybersecurity controls and technical documentation for medical devices.
• Experience preparing technical files or FDA submissions.

Work Environment:

• Hybrid working with 3 days per week in the Melksham office.
• Comfortable office environment with pool table, ping pong table and shower.
• Onsite gym & access to recovery suite including sauna and ice bath.
• Additional days leave for birthday.
• From time to time there might be a need to travel to customers' premises.

Why Join Periculo?

You'll be working with some of the most exciting digital health and MedTech innovators in the UK and Europe, helping them launch technologies that genuinely improve patient outcomes. You'll also join a team that values clarity, autonomy, and continuous improvement — with plenty of opportunities to shape how regulatory excellence is delivered at scale.

Job Type: Full-time

Pay: £35,000.00-£45,000.00 per year

Benefits:

• Casual dress
• Company pension
• Flexitime
• Health & wellbeing programme
• On-site gym
• On-site parking
• Work from home

Work Location: Hybrid remote in Melksham, SN12 8BT