At Thriva, we’re constantly trying new things to understand how we can improve people's lives by putting better health in their hands with tools they can trust, advice they can action, and the support to get them there.
We’re rated as the best preventative healthtech startup on TrustPilot and we’re only just getting started. We’re scaling fast and working hard to offer people the best level of understanding, support, and tracking throughout their health journey. We’re a Series A backed company and have raised c. £10m to-date with VCs like Target Global, Guinness Asset Management, and Pembroke VCT.
We’re looking for a Quality and Regulatory Associate to help ensure Thriva’s continued excellence when it comes to building products and services that put better health into people’s hands.
Meet our team!
You’ll be joining Thriva’s Delivery team who look after the health of the company and its customers by ensuring that quality, privacy and safety is at the heart of how we work. The Delivery team consists of clinical, operational, people, customer experience and compliance expertise, and we work cross functionally with other teams on a variety of projects. We’re also a mixture of gamers, thespians, pet enthusiasts and chefs.
About the role:
You’ll be reporting to our Risk & Compliance Manager and supporting our Quality Assurance Manager in implementing ISO 13485 and ensuring our Technical Files are up to date.
- Support the implementation of company’s Quality Management System (QMS)
- Supporting Quality system oversight of third party supplier related product complaints, change controls, deviations, management and escalation.
- Assist in transition of MDD Technical Files to MDR Technical Files
- Maintenance of Essential Requirement Checklists, Technical Files, and Declaration of Conformity for CE Marking
- Reviewing Promotional and Non-Promotional Marketing Materials (e.g. IFUs, packaging, labelling and marketing literature etc.)
- Experience in quality management systems (either in ISO 13485 or GMP or ISO 9001)
- Experience in regulatory affairs relating to medical devices
- Knowledge of the medical device industry and medical device regulations
- Very proficient in attention to details
- Passionate about Quality and Regulatory (Compliance)
- Strong communication and relationship building skills
- Be methodical, analytical and highly organised
How we work: During the pandemic we are working from home 100% of our time. Outside of the pandemic era, we offer flexible working options with a minimum of 2 days in office per week.
We embrace diversity at Thriva. To build a product that is loved by everyone we need a team with all kinds of different perspectives, experiences and backgrounds. That's why we're committed to hiring people from different backgrounds, race, religion, national origin, gender identity, sexual orientation, gender identity, age or disability.
We understand that applying for a new job takes a lot of work and we really value your time. We are really looking forward to reading your application!