Clinical Safety Officer

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 journeyfrom 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 systemsand growing fast.

What Youll Do as a Clinical Safety Officer

We are seeking a highly skilled and experienced Clinical Safety Officer to join our dynamic team.

The Clinical Safety Officer will play a pivotal role in our rapidly scaling health tech organisation ensuring the safety and regulatory compliance of our cutting-edge health technology solutions. This role involves monitoring and evaluating the safety of our products developing and implementing risk management plans and ensuring adherence to regulatory requirements. The ideal candidate will possess a strong background in clinical safety risk management and regulatory affairs within the health tech industry. They will collaborate with cross-functional teams to uphold the highest safety standards ensuring our innovative solutions improve patient outcomes while adhering to regulatory requirements.

Key Responsibilities:

Clinical Safety Management:

• Lead on clinical safety activities including compliance with NHS Digital DCB 0129/0160 UK MDR 2002 (SI 2002/618) and EU MDR 2017/745 under responsibility of the CMO/ DCMO.

• Develop implement and maintain clinical safety protocols and risk management plans according to ISO 13485 and ISO 14971.

• Monitor and evaluate the safety performance of health tech products throughout their lifecycle ISO 14971 ISO 13485 and DCB 0129/0160.

• Conduct safety assessments and risk analyses ensuring compliance with relevant regulatory requirements.

• Lead Clinical Safety meetings and represent clinical safety at Clinical Governance Meetings.

• Leading Hazard Workshops using structured methods (e.g. HAZID SWIFT) with multidisciplinary stakeholders such as developers clinicians and RAQA.

• Maintain and update Clinical Safety Case Reports and Hazard Logs in line with DCB 0129/0160 and manage the organisational incident log to support learning and continuous improvement.

• Stay current with clinical safety standards and regulatory guidelines relevant to health technology.

Regulatory Compliance:

• Ensure all clinical safety activities comply with relevant regulations including DCB UK/EU MDR and other global standards.

• Prepare and maintain clinical evaluation reports (CERs) and other required documentation for regulatory submissions according to the most relevant guidelines.

• Assist in the preparation of technical files and regulatory submissions for market approval.

• Collaborate with regulatory affairs to address compliance-related issues or queries.

Adverse Event Reporting:

• Oversee the identification documentation and reporting of adverse events and incidents related to health tech products.

• Conduct thorough investigations of safety-related incidents and develop corrective and preventive actions (CAPAs).

• Ensure timely and accurate reporting of adverse events to regulatory authorities including documentation through appropriate systems

Cross-Functional Collaboration:

• Work closely with quality assurance regulatory affairs and clinical teams to ensure the safety and efficacy of health tech products.

• Provide clinical safety input during the development and post-market surveillance of health technology solutions.

• Participate in and when required lead cross-functional meetings and project teams to provide safety expertise.

Training and Education:

• Develop and deliver training programs on clinical safety and regulatory compliance for internal teams.

• Stay updated on emerging trends and changes in regulatory requirements related to clinical safety in health technology.

• Mentor and guide junior team members on best practices in clinical safety and regulatory compliance.

Experience Were Looking For:

• Advanced degree in a clinical field (e.g. MBBS RN Para PharmD PhD) required.

• Certification in clinical safety (e.g. NHS Digital Clinical Safety Officer Training) and current registration with a UK professional body (e.g. GMC NMC HCPC)

• Minimum of 3 years of experience working as a Clinical Safety Officerwithin the health technology industry under a QMS framework for Medical Device safety.

• Strong understanding of health technology and its regulatory landscape.

• In-depth knowledge of relevant regulations including DCB 0129/0160 EU MDR 2017/745 UK MDR 2002 ISO 14971 and ISO 13485 required.

• Start up experience (desirable)

• Excellent analytical skills and ability to interpret complex safety data.

• Strong written and verbal communication skills.

• Ability to work independently and collaboratively in a dynamic fast-paced environment.

• Excellent communication and interpersonal skills with the ability to effectively communicate complex clinical information to non-clinical stakeholders.

• Desirable: Proficiency in G-Suite Radar Jira and Confluence and safety database systems.

Key Competencies:

• Attention to detail and accuracy

• Strong organisational and project management skills

• Problem-solving and critical-thinking abilities

• Effective communication and interpersonal skills

• Ability to work under pressure and meet deadlines

• Skilled at influencing decisions through collaboration and expertise

Working Conditions:

• Full-time (or close to full-time)

• Office based in London with the possibility of remote work.

• Occasional travel may be required for meetings training and conferences.
  

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 and Stockholm. 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 roles are fully remote depending on the team and responsibilities.

What Youll Get

Annual Leave & Holidays
25 days annual leave up to 8 UK bank holidays
Option to buy or sell holidays

Remote Working
Flexible remote options
200 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*
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 leadershipwe 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 hiringregardless 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.