Job Overview

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:

1. Clinical Safety Management:
• Lead on clinical safety activities including compliance with NHS Digital DCB 0129/0160 standards under responsibility of the CMO/ Senior Medical Lead.
• Develop, implement, and maintain clinical safety protocols and risk management plans.
• Monitor and evaluate the safety performance of health tech products throughout their lifecycle.
• Conduct safety assessments and risk analyses, ensuring compliance with relevant regulatory requirements.
• Chair Clinical Safety meetings and represent clinical safety at Clinical Governance Meetings.
• Manage organisational incident log and share learning with stakeholders.
• Stay current with clinical safety standards and regulatory guidelines relevant to health technology.
2. Regulatory Compliance:
• Ensure all clinical safety activities comply with relevant regulations, including DCB, MDR, and other global standards.
• Prepare and maintain clinical evaluation reports (CERs) and other required documentation for regulatory submissions.
• Assist in the preparation of technical files and regulatory submissions for market approval.
• Collaborate with regulatory affairs to address compliance-related issues or queries.
3. 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.
4. 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 cross-functional meetings and project teams to provide safety expertise.
5. 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:

• Advanced degree in a clinical field (e.g., MBBS, RN, Para, PharmD) required.
• Certification in clinical safety.
• Minimum of 3 years of experience working as a Clinical Safety Officer within the healthcare (ideally health tech) industry.
• Strong understanding of health technology and its regulatory landscape.
• In-depth knowledge of relevant regulations, including DCB, MDR, and other global standards.
• 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, 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

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.