Location: Bristol, with a minimum of 2 days a week in the office.

About Us

OKKO Health is at the forefront of developing innovative medical software solutions, improving patient care through cutting-edge technology. As a dedicated Software as a Medical Device (SaMD) company, we are committed to maintaining the highest standards of quality and compliance in all aspects of our operations. We are looking for a motivated Senior Quality & Regulatory Manager to join our team.

Job Description

The Senior Quality & Regulatory Manager holds overall accountability for Regulatory, Quality Management, and risk at OKKO Health. Working cross-functionally, this role ensures compliance with standards including ISO 13485, 14971, 62304, IEC 82304 and other regulatory requirements such as those related to Medical Device Regulations (MDR) and FDA (including QMSR) across all territories in which OKKO Health operates.

Key Responsibilities

• Hold overall accountability for the OKKO Health Quality Management System (QMS) and Regulatory compliance framework.
• Oversee document control and maintenance for the QMS.
• Create, maintain, and oversee policies for ISO 13485, 14971, 62304, MDR, FDA and other relevant regulations.
• Provide line management and personal development of our QCR Administrator, setting performance goals and expectations, providing feedback and support.
• Support and train other OKKO team members to manage CAPAs, customer complaints, feedback, nonconformances, and design control processes.
• Set and monitor QMS objectives and KPIs.
• Lead management review meetings, risk management, and change management.
• Serve as Risk Manager, developing robust risk management strategies to identify, mitigate and manage risk across the organisation.
• Drive continual improvement, work on process improvement and automation initiatives, as well as supporting training activities to drive education on quality and regulatory aspects.
• Proactively plan and advise on changes to industry standards and regulatory requirements.
• Own quality and regulatory communications internally and externally, including with our notified body for MDR / ISO13485 audits, and with the FDA.
• Work closely with key members of the organisation to ensure the quality and regulatory operations aligns with product roadmap and commercial needs.

Qualifications

• 5+ years of management experience with proven business acumen, preferably in Biotech, Medical Device, or Healthtech start-up.
• Significant experience developing, implementing, managing and overseeing Quality Management Systems.
• In-depth understanding of quality & regulatory standards relating to Medical Devices including MDR, ISO 13485 and QMSR, pertaining particularly as they apply to Software as a Medical Device.
• Experience in attaining or maintaining MDR and FDA certifications is key.
• Understanding of the software development lifecycle.
• Demonstrated ability to develop initiatives and foster collaborations across all organisational levels.
• Strong organisational and project management skills.
• Excellent communication skills, both verbal and written.
• Proficient in Jira or other quality management software.
• Proficient in Google Suite (Docs, Sheets, Slides, Drive) or the Microsoft equivalent.

We Offer

• Competitive salary and benefits package (including Vitality Health Insurance).
• Opportunity to contribute to a dynamic and innovative healthcare team.
• Professional growth and development opportunities.
• Flexible working hours and remote work options.