- Experience Level
- Experienced (non-manager)
QA / QMS Analyst. In this role you will be responsible to create and implement the QMS at ISO13485 standard.
You will not find public information about the Client (just yet!) as it`s a health start-up on stealth mode. The Client aim to be the world's leading consumer health tech brand by making a real difference to human health and wellbeing. In doing so, It will move towards prevention, prediction, participation and personalisation as the dominant guardians of health and the key financial drivers of the healthcare industry. We will bring healthcare into the home and combine cutting edge technology with a consumer-first approach.
We are looking for a detail-oriented and passionate Quality Assurance Analyst. You respect rules and regulations but are not afraid to do things differently. You are able to understand the needs and challenges of each team to support and drive products to market; from R&D through Operations, Manufacturing, and Commercial. You are logical and can develop clear action plans and communicate them with confidence to suppliers and internally.
You have experience working within the Medical Device industry in a Quality and Regulatory focused role.
* 3+ years of relevant regulatory experience in IVD industry
* BsC or related degree in, Life Sciences, Engineering or a similar, or equivalent industrial or commercial experience within a Medical Device/IVD setting
Knowledge / Experience
* Experience in consumer and medical device product design and development.
* Developing Quality Management Systems and the ability to interpret regulations.
* Experience ensuring a high level of compliance with IVDD, IVDR, ISO 13485, 21 CFR 820, and cGMP
* Experience in complying with laboratory health, laboratory protocols and safety regulations
* Experience with preparation of reports and documents
* Experience with Greenlight Guru system or similar eQMS
* Experience in regulatory submissions outside of the EU/UK
Competitive Salary package + Bonus + Benefit