Job Title: Head of Quality and Regulatory
Job Reference: https://okkohealth.freshteam.com/jobs/2DEQNCLCKlwf/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 having ownership of the QMS.

You will have a strategic, pragmatic quality mindset, be proactive with a resolution driven attitude and will possess a 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. Report on Key Performance Indicators (KPIs) in order to ensure adherence to process and prevent occurrence of any non-conformity relating to products, processes or systems.

• Ensure product designs comply with Design Controls and are validated, ensuring compliance with regulatory requirements and follow change control. Ensure quality input in Design Reviews. Ensure quality representation at business gate reviews.

• Ensure detection of product and quality management system nonconformities and addressed through the use of the quality policy, quality objectives, audit results, post-market surveillance, analysis of data, corrective actions, preventive actions and management review.

• Maintain company regulatory registrations.

• Escalate issues directly to the CEO if necessary.

• Providing expert quality guidance across the business coaching and mentoring with business units to ensure quality is embedded across all related 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.

• Act as appointed Management Representative and Person Responsible for Regulatory Compliance (PRRC) 

• Support with 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 specific knowledge of requirements of GMP, ISO 13485, ISO 14971, MDR & IVDR (2017/745 & 746); US FDA CFR Part 820, Medical Device Single Audit Programme (MDSAP), IEC 62304, ISO 80002 and associated regulations.

• Proven experience in a similar quality leadership role, including experience 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 submission, review and approval of global applications.

• Proven experience in providing leadership, direction, and focus to company site quality to ensure operational excellence, structured growth, and long-term strategic management.

• Demonstrate a working understanding of regulatory, risk management (ISO14971), new technologies/trends, and design control related fields.

• Proven ability to work effectively and efficiently both within regulated environments and hybrid agile R&D environments, with the ability to adapt priorities to the business requirements effectively.

• Strong interpersonal, collaboration and negotiation skills, as well as leading and mentoring teams.

• Strategic thinker with the ability to influence at an executive level and develop positive stakeholder relationships.

• A confident leader who will drive simplification of processes, striving for a lean and nimble organisation.

• Desirable to have experience using electronic quality management systems.

• Desirable to have experience in writing and reviewing commercial quality agreements.

• Desirable to have experience in product development.

• Desirable to have 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.