Medical Device Compliance Specialist
21 hours ago
HealthHero Group is a digital-first, end-to-end healthcare provider connecting smart digital tools with gold-standard clinical expertise to enhance people's whole health and optimize healthcare efficiency.
We are seeking a highly experienced Clinical Governance and Regulatory Expert to work in our Clinical Product Team. As a key member of the team, you will provide support and guidance on all aspects of Product Quality, Compliance & Governance.
- This role involves acting as a Business Partner for the relevant Department/Business Area, with specific focus on Medical Device regulations.
- You will be responsible for managing the quality and compliance of the whole product lifecycle, including compliance and maintenance of relevant standards and certifications.
The estimated salary for this position is around $70,000 - $90,000 per annum, depending on experience.
Responsibilities:- Chair relevant meetings and committees as required as part of the Quality Management System.
- 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.
Requirements:
- Knowledge and experience of quality management and the governance of medical devices within an ISO 13485 accredited healthcare organization.
- Desirable – have experience of software as a medical device including MDR submissions.
- Company Pension scheme.
- Access to HealthHero Group 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.
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