Job Title
Head of Quality and Regulatory
Location
Bristol, with a minimum of 1 day a week in the office
Salary
£70,000-£80,000 Full-Time Equivalent
Employment Type
Permanent, with part-time working considered
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 Head of Quality and Regulatory to join our team.
Job Description
The Head of Quality and Regulatory is a key member of the management team, reporting directly to the CEO. This role is responsible for providing strategic and technical leadership for Quality and Regulatory compliance across all aspects of the business. Working cross‑functionally, you will be a key contact for external regulatory authorities as well as owning the QMS. You will have a strategic, pragmatic quality mindset, be proactive with a resolution‑driven attitude, and possess strong knowledge of medical device quality systems. You will be passionate about putting patient safety first and playing your part in creating a more effective, compliant and efficient business.
Key Responsibilities
* Lead and manage Quality and Regulatory teams to ensure all business, regulatory, compliance and team development requirements are met.
* Act as appointed Management Representative.
* Communicate the importance of meeting customer, statutory and regulatory requirements to staff.
* Directly responsible for the implementation, maintenance and continuous improvement of all aspects of the company Quality Management System.
* Establish and maintain Quality Objectives and report on Key Performance Indicators (KPIs) to ensure adherence to process and prevent non‑conformity.
* Ensure product designs comply with Design Controls and are validated, ensuring compliance with regulatory requirements and change control. Provide quality input in Design Reviews and representation at business gate reviews.
* Detect product and QMS nonconformities and address through quality policy, objectives, audit results, post‑market surveillance, data analysis, corrective actions, preventive actions and management review.
* Maintain company regulatory registrations.
* Escalate issues directly to the CEO if necessary.
* Provide expert quality guidance across the business, coaching and mentoring business units to embed quality across all activities.
* Manage the Quality function within budget, including resource planning for budgetary requirements and staffing resources on projects and QMS activities, driving continuous improvement and high levels of service.
* Support information security management system training.
Qualifications
* Qualified to degree level (science or engineering advantageous).
* Extensive experience (10+ years) in a medical device regulated manufacturing environment with knowledge of GMP, ISO 13485, ISO 14971, MDR & IVDR (2017/745 & 746), US FDA CFR Part 820, MDSAP, IEC 62304, ISO 80002 and associated regulations.
* Proven experience in a similar quality leadership role, including dealing with certification bodies, notified bodies or competent authorities.
* Experience in understanding, interpreting and advising on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of devices to expedite global submissions.
* Leadership experience to ensure operational excellence, structured growth and long‑term strategic management.
* Working knowledge of regulatory, risk management (ISO 14971), new technologies/trends, and design control related fields.
* Ability to work effectively both within regulated environments and hybrid agile R&D environments, adapting priorities to business requirements.
* Strong interpersonal, collaboration and negotiation skills, and capability to lead and mentor teams.
* Strategic thinker able to influence at an executive level and develop positive stakeholder relationships.
* Confident leader who drives simplification of processes, striving for a lean and nimble organization.
* Desirable: experience using electronic quality management systems.
* Desirable: experience in writing and reviewing commercial quality agreements.
* Desirable: experience in product development.
* Desirable: experience in information security/GDPR/HIPAA.
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.
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