Developing an innovative analytics solution that alerts clinical teams about a patient’s deterioration, enabling early intervention and improving clinical outcomes
About The Position
- Defining, implementing, managing and controlling Clew Medical Quality System for compliance with the requirements of ISO13485, and USA 21 CFR§820 Quality and Regulation and IEC 62304- Software life cycle processes system.
- Support the regulatory activities for new and existing products including regulatory submissions (FDA, CE, AMAR).
- Guiding R&D, Marketing, Clinical personnel as well as subcontractors regarding quality and regulatory requirements.
- Manage Engineering Change Orders (ECO) – initiate and manage software change orders.
- Managing Customer Complaints process and customer’s DHR
- Managing yearly ISO audits, ongoing DHF and CAPA process
· Maintain and update the Approved Supplier List (ASL)
- Support Reporting products changes to regulatory bodies as required.
- Reporting incidents (adverse events) to the applicable regulatory bodies/agencies
- Reporting quality system performance to the company's management for review and initiation of improvement actions. (Annual management quality review)
Ensuring the promotion of awareness and training, of quality and of regulatory and customer requirements throughout the organization.
· B.A or B.Sc. degree in a relevant field
· 1-3 years Quality Assurance/Regulatory experience as QA/RA expert in the medical device company.
· Knowledge in ISO13485, FDA QSR, and EU MDR requirements
· Experience with software medical device (IEC62304, SDLC)- is preferred.
· Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European
competent authorities & notified bodies, Health Canada, etc.
· Experience of routine QA activities: CAPA, MRB, ECO, Complaints etc..
· Demonstrated management skills; ability to prioritize, plan, evaluate & execute deliverables for established tactical goals.
· Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level
products & related processes.
· Proactive leader with strong ownership and excellent interpersonal relationships
· English Proficiency.
At CLEW, you will have the opportunity to work alongside the world’s most talented researchers, data scientists, engineers, finance and sales professionals to meet the rising demand for high-quality care in today’s post-pandemic world. No matter what position you are in, you will become a full partner in our life-changing mission.
Our emphasis on innovation encourages higher levels of creativity and out-of-the-box thinking that empowers our employees to reach their maximum potential. It has also enabled us to fuse the highest standards of care with the latest ML/AI tools to redefine the future of critical care.
A healthy work/life balance
We believe that quality time outside of the workplace is vital to our employees’ mental health and overall satisfaction. At CLEW, we encourage flexible scheduling, company-sponsored health initiatives, and giving back to our communities through volunteerism.
Our Virtual ICU product is deployed in some of the leading critical care facilities in the US and we have strong financial backing from Israel’s leading venture capital funds. We are at a critical stage in product development and are looking for people to join the team who are as excited as we are.
Work space and environment
We believe that an engaging and convenient work environment is necessary to foster communication and productivity. We work hard together, and play hard together too. Luckily, at CLEW, there are no shortage of reasons to have fun and celebrate together.
An engaging work environment with an emphasis on convenience and creativity to foster communication and productivity.