RAQA Lead

A Bit About Us

Were Doccla and were redefining where and how healthcare is delivered.

Our Virtual Ward and Remote Monitoring Solutions enable hospitals and health systems to care for patients at home. We support patients across the full care journey from early discharge and acute recovery to long-term condition management and proactive care.

We provide everything clinicians need to deliver safe effective Virtual Care: medical-grade devices logistics patient onboarding EHR integration and an end-to-end clinical platform built around real-world workflows.

We currently work with over 60% of NHS ICBs and supporting health systems across the including UK Ireland France and the DACH region to reduce hospital pressure improve outcomes and create a more resilient model of care.

Were backed by top European investors having secured 35m in Series B funding led by Lakestar with participation from Elaia General Catalyst Speedinvest and Bertelsmann.

Why Join Us

This is your chance to join Doccla at a key stage in our growth.

Were building the category leader in Virtual Care and Remote Patient Monitoring. Youll be part of a highly entrepreneurial mission-driven team that combines expertise across clinical technical commercial and operational domains.

Were solving real problems for patients and health systems and growing fast.

What Youll Do as a RA/QA Lead

The Senior RAQA Lead is a senior individual contributor and operational lead within the Regulatory

Affairs and Quality Assurance function. Reporting to the Head of Regulatory and Compliance this role

owns day-to-day quality assurance across the software development lifecycle and provides regulatory

expertise to support active EU MDR conformity assessment post-market obligations and cross-

functional product quality processes.

This role is suited to a quality and regulatory professional with deep SaMD and software lifecycle

experience who can operate independently manage complex workstreams and embed quality

practices directly within engineering and product development processes.

What Experience Youll Bring to the Team

Software Quality Assurance

Own and maintain quality processes across the software development lifecycle in accordance

with IEC 62304 including software classification unit decomposition and verification and

validation activities.

Embed quality gates within engineering workflows ensuring change control software release

and defect management processes meet regulatory requirements.

Lead software problem resolution and non-conformance processes including root cause

analysis and CAPA management.

Define and maintain software quality metrics traceability matrices and test documentation to

support Technical Documentation and audit readiness.

Collaborate with engineering leads to maintain the software development and maintenance plan

and ensure IEC 62304 artefacts are complete and current.

Quality Management System

Own and maintain the QMS ensuring continued compliance with ISO 13485 and EU MDR

requirements.

Lead the internal audit programme with a focus on software and product quality processes.

Prepare for and support external audits including Notified Body surveillance audits.

Maintain document control processes and ensure version integrity across the quality system.

Regulatory Affairs

Support maintenance and continuous improvement of the EU MDR Technical Documentation

including software documentation intended purpose risk management and clinical evaluation.

Monitor and assess regulatory intelligence across EU MDR and applicable international

frameworks communicating impact to the Head of Regulatory and Compliance.

Coordinate with Notified Body contacts and the EU Authorised Representative on conformity

assessment activities.

Support post-market surveillance and vigilance activities including PMCF planning and PSUR

preparation.

Risk Management

Maintain the risk management file in accordance with ISO 14971 with particular focus on

software-related hazards and use error scenarios.

Conduct and document risk assessments for product changes software updates new features

and new indications.

Integrate risk outputs with clinical evaluation software lifecycle documentation and post-market

processes.

Cross-functional Collaboration

Act as the primary RAQA contact for product and engineering teams providing regulatory and

quality input at design review sprint and release stages.

Support clinical evidence activities including real-world evidence study design and CER/CEP

documentation.

Contribute regulatory perspective to AI and algorithm governance including EU AI Act

obligations where applicable.

Team and Operations

Provide operational oversight of RAQA workstreams and contribute to team planning and

prioritisation.

Mentor and support junior RAQA team members where applicable.

Drive RAQA process improvement tooling and automation initiatives.

What Were Looking For

Essential

Significant experience in quality assurance or regulatory affairs within the medical device or

digital health industry (minimum 5 years).

Demonstrable expertise in IEC 62304 software lifecycle processes for medical device software.

Strong working knowledge of EU MDR (2017/745) and ISO 13485.

Experience with SaMD products ideally in a cloud-hosted or platform context.

Proven ability to work directly with engineering and product teams to embed quality practices.

Familiarity with Technical Documentation requirements including software documentation

clinical evaluation and risk management files.

Excellent written communication skills with the ability to produce precise regulatory and quality

documentation.

Desirable

Knowledge of ISO 14971 and usability engineering (IEC 62366).

Exposure to post-market surveillance vigilance and PMCF activities.

Familiarity with EU AI Act obligations relevant to software as a medical device.

Experience working with Notified Bodies or Authorised Representatives.

Background in virtual care remote monitoring or digital therapeutics.

Experience with cybersecurity standards relevant to connected medical devices (e.g. IEC

).

How We Work

We empower everyone at Doccla to take ownership of their work and the companys mission. We act ethically and always put patient safety and outcomes first.

To thrive here youll need a can-do attitude and an action-oriented approach along with a willingness to learn and grow through open feedback.

Were a hybrid team with offices in London Denmark Germany. Most of our team is London-based and enjoys in-person time at our WeWork HQ 13 days per week where youll find great lunch barista coffee and a pet-friendly space. Some of our teams are fully remote depending on the team and responsibilities. This includes our Engineering Clinical & Patient Support teams.

What Youll Get

Annual Leave & Holidays
25 days annual leave up to 8 UK bank holidays this varies depending on the role
Option to buy or sell holidays

Remote Working
Flexible remote options
Remote working stipend

Financial Benefits
Employee stock options
4% pension on full basic pay
4x salary life insurance

Health & Wellness
Private health insurance
4 months full pay for birthing parent*
4 weeks full pay for non-birthing parent*
Phased return back to paid work
Sick pay

In-Office Perks (London HQ)
Free daily lunch
Pet-friendly office

Other Benefits
500 L&D budget per person
Cycle to work scheme

Via Smart Health:
24/7 GP appointments
Mental health support
Nutrition & fitness advice
Second opinions & health checks

In Return for Your Hard Work

• A competitive compensation package (base stock options) with half-year and annual performance reviews

• The chance to work on patient-first system-level healthcare challenges in one of Europes leading healthtech companies

• Opportunities for growth and leadership we want you to challenge the status quo own your impact and continue developing with our full support

Diversity at Doccla

We embrace diversity. To build a great product we need a team with a wide range of perspectives backgrounds and experiences.

Were committed to equal opportunity hiring regardless of race religion gender identity sexual orientation age disability or background. If youre excited about the role we encourage you to apply even if your experience doesnt match every point.

Safer Recruitment

We are committed to safer recruitment practices. As Doccla is a CQC registered company a Disclosure and Barring Service (DBS) check will be required for all roles.

It is an offence to apply for such work if you are barred from working with children or vulnerable adults.