HealthHero is a digital-first, end-to-end healthcare provider. We connect smart digital tools with gold-standard clinical expertise to enhance people’s whole health and optimise healthcare efficiency. Active in the UK, Ireland, France and Germany, our mission is simplifying healthcare, improving lives. Being the European market leader, HealthHero is leading the way on shaping the virtual healthcare industry.
We are seeking a Quality and Compliance Manager to work in our Clinical Product Team. In this role you will:
- Provide support and guidance to the organisation on all aspects of Product Quality, Compliance & Governance,
- Act as a Business Partner for therelevant Department/Business Area, with specific focus on Medical Device regulations
- Manage the quality and compliance of the whole product lifecycle, including compliance and maintenance of relevant standards and certifications.
You will be a reference point to the organisation and a champion of our Quality and improvement culture, for all areas of Clinical Product governance and the subject matter expert in their specialist area.
You will be required to exercise discretion, initiative, pragmatism, independent judgement and decision making and have the ability to deliver a high-quality service at all times.
The role is suitable for hybrid working from home and at our Bracknell office and may involve some travel to other HealthHero sites or external partners as required.
Requirements
Management and coordination of the Clinical Product Quality and Compliance function, ensuring effective engagement with our product, technical and client services teams and external stakeholders where appropriate.
Supporting and enabling our Clinical Product family and market expansion plans, using judgement and experience when liaising with key stakeholders, to escalate complex queries or issues to colleagues, the Compliance Director or Clinical Safety Officer as required.
Key Responsibilities:
- Chair relevant meetings and committees as required as part of the Quality Management System
- Ensuring effective systems and processes for proactive development of the HealthHero Clinical Product family and the integration of HealthHero functions and entities
- Lead the process of transitioning our Class 1 Medical Devices to Class 2a under the EU MDR framework, acting as the point of contact with the Notified Body
- Leading preparations for ISO13485 audits and working with the Governance Team to ensure that our certified quality management system is maintained throughout the year
- Ensure compliance with clinical risk management standards through manufacturing, implementation and documentation
- Lead support and liaison with teams and stakeholders, acting as a point of escalation for governance of Clinical Product development, specifications and customer requirements
- Providing information for reported Quality and Safety Issues, enabling the Compliance Director and Clinical Safety Officer to be informed in the in the appropriate escalation and reporting to relevant stakeholders including MHRA
- Ensuring effective systems to evidence Clinical Product performance to specification and clarify the responsibilities of each partner and stakeholder within product development
- Auditing of key systems, ensuring appropriate and effective documentation of processes including training and support materials
- Compiling and maintaining QA documentation to support business development, including reviewing bid responses, providing information for applications for procurement frameworks and for diligence activities
- Manage the creation and maintenance of Clinical Product Safety Documentation and Technical Files, within the required timescales and in compliance to relevant regulatory standards
- Ensure the development and implementation of processes to monitor and report any actions resulting from recommendations of internal and external audit reviews.
- Provide support and advice to staff across the organisation in the implementation and review of localised requirements for compliance, governance and regulations within the global market
- Provide periodic reporting to the Governance Team and other Stakeholders.
- Depending on the business need, have line management responsibilities.
Accountability:
You will report directly to the Compliance Director
Requirements:
- Knowledge and experience of quality management and the governance of medical devices within an ISO 13485 accredited healthcare organisation
- Able to gather and assimilate information quickly and effectively
- Ability to write and contribute to complex documents and reports
- Understanding of audit and its application in practice
- Working knowledge of healthcare regulation, standards and guidelines
- Educated to degree level or equivalent
- Desirable – have experience of software as a medical device including MDR submissions
Personal qualities & behaviours required:
- Tenacity
- Credibility
- Resilience
- Articulate
- Appropriate DBS clearance
Benefits
- Company Pension scheme
- Access to HealthHero healthcare services, including Private 24/7 GP service and Employee Assistance Programme
- 25 days holiday +8 days bank holiday and an extra day off for your birthday
- Electric Car scheme
- Cycle to work scheme
- Salary Exchange scheme
